FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25957302 Type 1
Non-Serious
SEPTOCAINE, standard syringes with a harpoon
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019776
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product container seal issue (v28.1) Unknown

Drugs (2)

SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 004 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: 020971 | Batch#: D04767A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
standard syringes with a harpoon (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Darby: 37012070510

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c9", "safetyreportid": "25957302", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019776", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product container seal issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": "020971", "drugbatchnumb": "D04767A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "standard syringes with a harpoon", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Darby", "duplicatenumb": "37012070510" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25957305 Type 1
Non-Serious
ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE, MEPIVACAINE HYDROCHLORIDE, Henry Schein Standard Needles
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019861
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
7.0 (unit: 800)
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Therapeutic product effect decreased (v28.1) Unknown
No adverse event (v28.1) Unknown

Drugs (3)

ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 004 | Dosage: 3 CARPULES. | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04485B | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEPIVACAINE HYDROCHLORIDE (MEPIVACAINE HYDROCHLORIDE) Suspect
Route: 004 | Dosage: 3 CARPULES. | Form: Solution for injection | Indication: Local anaesthesia | Action: --
Auth#: -- | Batch#: D04888G | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Henry Schein Standard Needles (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Benco: BY955056

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c8", "safetyreportid": "25957305", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019861", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 7.0, "patientonsetageunit": 800, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "No adverse event", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": "D04485B", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 CARPULES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MEPIVACAINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "D04888G", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 CARPULES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MEPIVACAINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Henry Schein Standard Needles", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Benco", "duplicatenumb": "BY955056" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957301 Type 1
Non-Serious
ARTICADENT
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019753
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
48.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
90.71 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (1)

ARTICADENT (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 004 | Dosage: 3 CARPULES | Form: Solution for injection | Indication: Dental local anaesthesia | Action: Dose Reduced
Auth#: 020971 | Batch#: D05060B | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/03/2025 | End: 06/03/2025 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250603

Report Duplicates (1)

Dentsply: PR2166981

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c7", "safetyreportid": "25957301", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019753", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 48.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 90.71, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ARTICADENT", "drugauthorizationnumb": "020971", "drugbatchnumb": "D05060B", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 CARPULES", "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Dental local anaesthesia", "drugstartdateformat": "102", "drugstartdate": "2025-06-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-06-03T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 2, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250603" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Dentsply", "duplicatenumb": "PR2166981" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957303 Type 1
Non-Serious
ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019922
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (1)

ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D05104A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Dentsply: 2169065

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c6", "safetyreportid": "25957303", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019922", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": "D05104A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Dentsply", "duplicatenumb": "2169065" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25957300 Type 1
Non-Serious
ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019794
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (1)

ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04637B | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/13/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250613

Report Duplicates (1)

Patterson: 200483072

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c5", "safetyreportid": "25957300", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019794", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": "D04637B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": "102", "drugstartdate": "2025-06-13T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250613" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Patterson", "duplicatenumb": "200483072" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957293 Type 1
Non-Serious
SEPTOCAINE
Report Version
2
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019803
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (1)

SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: 020971 | Batch#: D04572A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Henry Schein: 126134

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c4", "safetyreportid": "25957293", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019803", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": "020971", "drugbatchnumb": "D04572A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Henry Schein", "duplicatenumb": "126134" } ], "reporttype": 1, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957299 Type 1
Non-Serious
ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE, MEPIVACAINE HYDROCHLORIDE, Henry Schein Standard Needles
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019860
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
7.0 (unit: 800)
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Therapeutic product effect decreased (v28.1) Unknown
No adverse event (v28.1) Unknown

Drugs (3)

ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 004 | Dosage: 3 CARPULES. | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04485B | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MEPIVACAINE HYDROCHLORIDE (MEPIVACAINE HYDROCHLORIDE) Suspect
Route: 004 | Dosage: 3 CARPULES. | Form: Solution for injection | Indication: Local anaesthesia | Action: --
Auth#: -- | Batch#: D04888G | Structured Dosage: 3.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Henry Schein Standard Needles (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Benco: BY955056

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c3", "safetyreportid": "25957299", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019860", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 7.0, "patientonsetageunit": 800, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect decreased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "No adverse event", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE", "drugauthorizationnumb": null, "drugbatchnumb": "D04485B", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 CARPULES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MEPIVACAINE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "D04888G", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "3 CARPULES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MEPIVACAINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Henry Schein Standard Needles", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Benco", "duplicatenumb": "BY955056" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957296 Type 1
Non-Serious
SEPTOCAINE AND EPINEPHRINE, SEPTOCAINE AND EPINEPHRINE, Gibson 30Ga Short needles
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019801
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug effect less than expected (v28.1) Unknown
No adverse event (v28.1) Unknown

Drugs (3)

SEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: 4 CARTRIDGES. | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: 020971 | Batch#: D04921A | Structured Dosage: 4.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: 4 CARTRIDGES. | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: 020971 | Batch#: D04852B | Structured Dosage: 4.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Gibson 30Ga Short needles (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Not available: EUt available

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c2", "safetyreportid": "25957296", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019801", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug effect less than expected", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "No adverse event", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE AND EPINEPHRINE", "drugauthorizationnumb": "020971", "drugbatchnumb": "D04921A", "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 CARTRIDGES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE AND EPINEPHRINE", "drugauthorizationnumb": "020971", "drugbatchnumb": "D04852B", "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "4 CARTRIDGES.", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Gibson 30Ga Short needles", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Not available", "duplicatenumb": "EUt available" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25957297 Type 1
Non-Serious
SEPTOCAINE, SEPTOCAINE, SEPTOCAINE (+6 more)
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019853
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Drug ineffective (v28.1) Unknown

Drugs (9)

SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D05007A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: B32752AA | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04766A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04911B | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04623A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04532C | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04637C | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 065 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: D04767A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
30 Gauge Patterson Blue Needle (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Dental local anaesthesia | Action: --
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Patterson: 200501995

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c1", "safetyreportid": "25957297", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019853", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D05007A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "B32752AA", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D04766A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D04911B", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D04623A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D04532C", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": null, "drugbatchnumb": "D04637C", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, 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"drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "30 Gauge Patterson Blue Needle", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Patterson", "duplicatenumb": "200501995" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25957295 Type 1
Non-Serious
SEPTOCAINE
Report Version
1
Receive Date
10/24/2025
Receipt Date
10/24/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SEPTODONT-2025019777
Authority Number
--
Sender Organization
SEPTODONT
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product container seal issue (v28.1) Unknown

Drugs (1)

SEPTOCAINE (ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE) Suspect
Route: 004 | Dosage: -- | Form: Solution for injection | Indication: Dental local anaesthesia | Action: --
Auth#: 020971 | Batch#: D04767A | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

Darby: 37012070510

Raw JSON (click to expand)

{ "_id": "69d4359f3b3830196fa566c0", "safetyreportid": "25957295", "authoritynumb": null, "companynumb": "US-SEPTODONT-2025019777", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product container seal issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SEPTOCAINE", "drugauthorizationnumb": "020971", "drugbatchnumb": "D04767A", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "004", "drugindication": "Dental local anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARTICAINE HYDROCHLORIDE\\EPINEPHRINE BITARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-24T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-24T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Darby", "duplicatenumb": "37012070510" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SEPTODONT" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }