FDA FAERS Adverse Event Reports

25967153 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/19/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007466

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

39.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

56.7 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (10)

Uterine leiomyoma (v28.1) Not Recovered

Fibrosis (v28.1) Unknown

Device breakage (v28.1) Not Recovered

Foreign body in reproductive tract (v28.1) Not Recovered

Complication of device removal (v28.1) Not Recovered

Emotional distress (v28.1) Unknown

Abnormal uterine bleeding (v28.1) Not Recovered

Dyspareunia (v28.1) Unknown

Device use issue (v28.1) Unknown

Off label use (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Not Applicable

Start: 10/02/2009 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200401

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4ee9",
  "safetyreportid": "25967153",
  "authoritynumb": null,
  "companynumb": "US-COOPERSURGICAL, INC.-2025CPS007466",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 39.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 56.7,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Uterine leiomyoma",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Fibrosis",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device breakage",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Foreign body in reproductive tract",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Complication of device removal",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Emotional distress",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abnormal uterine bleeding",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dyspareunia",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device use issue",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PARAGARD T 380A",
        "drugauthorizationnumb": "018680",
        "drugbatchnumb": null,
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Intrauterine",
        "drugadministrationroute": "015",
        "drugindication": "Contraception",
        "drugstartdateformat": "102",
        "drugstartdate": "2009-10-02T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": 3,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "COPPER"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200401"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "COOPERSURGICAL"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-19T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967152 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007470

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

24.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

61.224 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (14)

Reproductive complication associated with device (v28.1) Unknown

Female sterilisation (v28.1) Recovered

Device breakage (v28.1) Recovered

Foreign body in reproductive tract (v28.1) Recovered

Complication of device removal (v28.1) Recovered

Procedural pain (v28.1) Recovered

Emotional distress (v28.1) Unknown

Sexual dysfunction (v28.1) Unknown

Abnormal uterine bleeding (v28.1) Unknown

Heavy menstrual bleeding (v28.1) Unknown

Device expulsion (v28.1) Recovered

Menstrual disorder (v28.1) Unknown

Device use issue (v28.1) Recovered

Off label use (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: -- | Action: Not Applicable

Start: 09/20/2007 | End: 04/01/2021 | Duration: 4943.0 day | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20070920

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4ee8",
  "safetyreportid": "25967152",
  "authoritynumb": null,
  "companynumb": "US-COOPERSURGICAL, INC.-2025CPS007470",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 24.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 61.224,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Reproductive complication associated with device",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Female sterilisation",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device breakage",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Foreign body in reproductive tract",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Complication of device removal",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Procedural pain",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Emotional distress",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Sexual dysfunction",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abnormal uterine bleeding",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Heavy menstrual bleeding",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device expulsion",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Menstrual disorder",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device use issue",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Off label use",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PARAGARD T 380A",
        "drugauthorizationnumb": "018680",
        "drugbatchnumb": "056007",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Intrauterine",
        "drugadministrationroute": "015",
        "drugindication": null,
        "drugstartdateformat": "102",
        "drugstartdate": "2007-09-20T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2021-04-01T00:00:00",
        "drugtreatmentduration": 4943.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "COPPER"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20070920"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "COOPERSURGICAL"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967151 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007461

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

86.168 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (22)

Surgery (v28.1) Recovered

Device breakage (v28.1) Not Recovered

Foreign body in reproductive tract (v28.1) Not Recovered

Complication of device removal (v28.1) Not Recovered

Embedded device (v28.1) Not Recovered

Abdominal pain upper (v28.1) Not Recovered

Peripheral swelling (v28.1) Not Recovered

Emotional distress (v28.1) Unknown

Urinary tract infection (v28.1) Unknown

Vulvovaginal pruritus (v28.1) Unknown

Vulvovaginal erythema (v28.1) Unknown

Vulvovaginal discomfort (v28.1) Unknown

Endometrial thickening (v28.1) Unknown

Infection (v28.1) Not Recovered

Abnormal uterine bleeding (v28.1) Not Recovered

Vaginal discharge (v28.1) Unknown

Vaginal infection (v28.1) Unknown

Heavy menstrual bleeding (v28.1) Unknown

Dysmenorrhoea (v28.1) Unknown

Menstruation irregular (v28.1) Unknown

Pelvic pain (v28.1) Unknown

Intermenstrual bleeding (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Not Applicable

Start: 09/11/2015 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230101

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4ee6",
  "safetyreportid": "25967151",
  "authoritynumb": null,
  "companynumb": "US-COOPERSURGICAL, INC.-2025CPS007461",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": null,
    "patientonsetageunit": null,
    "patientagegroup": null,
    "patientweight": 86.168,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Surgery",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device breakage",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Foreign body in reproductive tract",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Complication of device removal",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Embedded device",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abdominal pain upper",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Peripheral swelling",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Emotional distress",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Urinary tract infection",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vulvovaginal pruritus",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vulvovaginal erythema",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vulvovaginal discomfort",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Endometrial thickening",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Infection",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Abnormal uterine bleeding",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vaginal discharge",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Vaginal infection",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Heavy menstrual bleeding",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysmenorrhoea",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Menstruation irregular",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Pelvic pain",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intermenstrual bleeding",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PARAGARD T 380A",
        "drugauthorizationnumb": "018680",
        "drugbatchnumb": "514004",
        "drugstructuredosagenumb": null,
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        "drugseparatedosagenumb": null,
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Intrauterine",
        "drugadministrationroute": "015",
        "drugindication": "Contraception",
        "drugstartdateformat": "102",
        "drugstartdate": "2015-09-11T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "COPPER"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230101"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "COOPERSURGICAL"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967148 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007477

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

39.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

74.83 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Reproductive complication associated with device (v28.1) Unknown

Device breakage (v28.1) Not Recovered

Foreign body in reproductive tract (v28.1) Not Recovered

Complication of device removal (v28.1) Not Recovered

Device expulsion (v28.1) Not Recovered

Emotional distress (v28.1) Not Recovered

Intermenstrual bleeding (v28.1) Recovered

Muscle spasms (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Not Applicable

Start: 09/14/2016 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200301

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4ee5",
  "safetyreportid": "25967148",
  "authoritynumb": null,
  "companynumb": "US-COOPERSURGICAL, INC.-2025CPS007477",
  "duplicate": null,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "US",
  "patient": {
    "patientonsetage": 39.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 74.83,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Reproductive complication associated with device",
        "reactionoutcome": 6
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device breakage",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Foreign body in reproductive tract",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Complication of device removal",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Device expulsion",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Emotional distress",
        "reactionoutcome": 3
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Intermenstrual bleeding",
        "reactionoutcome": 1
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Muscle spasms",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "PARAGARD T 380A",
        "drugauthorizationnumb": "018680",
        "drugbatchnumb": "515004",
        "drugstructuredosagenumb": null,
        "drugstructuredosageunit": null,
        "drugseparatedosagenumb": null,
        "drugintervaldosageunitnumb": null,
        "drugintervaldosagedefinition": null,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": "UNK",
        "drugdosageform": "Intrauterine",
        "drugadministrationroute": "015",
        "drugindication": "Contraception",
        "drugstartdateformat": "102",
        "drugstartdate": "2016-09-14T00:00:00",
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          "activesubstancename": "COPPER"
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      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200301"
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  "primarysource": {
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    "qualification": 5,
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  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967149 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/19/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007439

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

--

Patient Age Group

--

Patient Sex

Female

Patient Weight

49.887 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (17)

Reproductive complication associated with device (v28.1) Unknown

Device breakage (v28.1) Recovered

Foreign body in urogenital tract (v28.1) Recovered

Complication of device removal (v28.1) Recovered

Embedded device (v28.1) Recovered

Emotional distress (v28.1) Unknown

Uterine spasm (v28.1) Not Recovered

Infection susceptibility increased (v28.1) Unknown

Libido decreased (v28.1) Unknown

Anxiety (v28.1) Unknown

Depression (v28.1) Unknown

Anger (v28.1) Unknown

Abnormal uterine bleeding (v28.1) Not Recovered

Menstruation irregular (v28.1) Unknown

Pelvic pain (v28.1) Unknown

Vaginal haemorrhage (v28.1) Unknown

Pain (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Not Applicable

Start: 07/30/2007 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20160101

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4ee4",
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}
                        

25967147 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/18/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007442

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

36.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

68.027 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (12)

Reproductive complication associated with device (v28.1) Unknown

Surgery (v28.1) Recovered

Device breakage (v28.1) Recovered

Foreign body in reproductive tract (v28.1) Recovered

Complication of device removal (v28.1) Recovered

Embedded device (v28.1) Recovered

Abortion spontaneous (v28.1) Recovered

Emotional distress (v28.1) Unknown

Procedural haemorrhage (v28.1) Recovered

Discomfort (v28.1) Recovered

Pain (v28.1) Recovered

Device expulsion (v28.1) Recovered

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Withdrawn

Start: 12/26/2013 | End: 10/13/2021 | Duration: 2849.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20211001

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
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  "transmissiondateformat": "102"
}
                        

25967146 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007476

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

39.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

81.633 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (10)

Surgery (v28.1) Recovered

Reproductive complication associated with device (v28.1) Unknown

Device breakage (v28.1) Recovered

Complication of device removal (v28.1) Recovered

Embedded device (v28.1) Recovered

Abortion spontaneous (v28.1) Recovered

Emotional distress (v28.1) Not Recovered

Device issue (v28.1) Recovered

Vaginal infection (v28.1) Unknown

Device dislocation (v28.1) Recovered

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Withdrawn

Start: 08/08/2016 | End: 03/22/2018 | Duration: 592.0 day | Rechallenge: -- | Additional: Yes

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20180207

Report Duplicates (0)

--

Raw JSON (click to expand)

                            {
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  "transmissiondateformat": "102"
}
                        

25967150 Type 1

Serious

PARAGARD T 380A

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/17/2026

Primary Source Country

US

Occurrence Country

US

Reporter Country

US

Reporter Qualification

Consumer

Literature Reference

--

Company Number

US-COOPERSURGICAL, INC.-2025CPS007438

Authority Number

--

Sender Organization

COOPERSURGICAL

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

--

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

37.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

61.224 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Surgery (v28.1) Recovered

Device breakage (v28.1) Recovered

Foreign body in urogenital tract (v28.1) Recovered

Complication of device removal (v28.1) Recovered

Emotional distress (v28.1) Not Recovered

Off label use (v28.1) Unknown

Device use issue (v28.1) Unknown

Drugs (1)

PARAGARD T 380A (COPPER) Suspect

Route: 015 | Dosage: UNK | Form: Intrauterine | Indication: Contraception | Action: Not Applicable

Start: 01/01/2007 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20171011

Report Duplicates (0)

--

Raw JSON (click to expand)

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      {
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        "drugindication": "Contraception",
        "drugstartdateformat": "102",
        "drugstartdate": "2007-01-01T00:00:00",
        "drugenddateformat": null,
        "drugenddate": null,
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 4,
        "actiondrug": 6,
        "activesubstance": {
          "activesubstancename": "COPPER"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20171011"
  },
  "primarysource": {
    "reportercountry": "US",
    "qualification": 5,
    "literaturereference": null
  },
  "primarysourcecountry": "US",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "COOPERSURGICAL"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": 2,
  "seriousnessdeath": 2,
  "seriousnessdisabling": 2,
  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967145 Type 1

Serious

HERCEPTIN, DOCETAXEL, CARBOPLATIN

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/18/2026

Primary Source Country

CN

Occurrence Country

CN

Reporter Country

CN

Reporter Qualification

Other Health Professional

Literature Reference

--

Company Number

CN-ROCHE-10000419915

Authority Number

--

Sender Organization

ROCHE

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

60.0 yr

Patient Age Group

Adult

Patient Sex

Female

Patient Weight

--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Unknown

Drugs (3)

HERCEPTIN (TRASTUZUMAB) Suspect

Route: 058 | Dosage: -- | Form: Powder injection | Indication: Invasive breast carcinoma | Action: Unknown

Start: 09/23/2025 | End: 09/23/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

DOCETAXEL (DOCETAXEL) Suspect

Route: 042 | Dosage: -- | Form: Injection | Indication: Invasive breast carcinoma | Action: Unknown

Start: 09/23/2025 | End: 09/23/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

CARBOPLATIN (CARBOPLATIN) Suspect

Route: 042 | Dosage: -- | Form: Powder injection | Indication: Invasive breast carcinoma | Action: Unknown

Start: 09/23/2025 | End: 09/23/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250929

Report Duplicates (1)

NMPACDR: 3501021025896202501730

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4edd",
  "safetyreportid": "25967145",
  "authoritynumb": null,
  "companynumb": "CN-ROCHE-10000419915",
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CN",
  "patient": {
    "patientonsetage": 60.0,
    "patientonsetageunit": 801,
    "patientagegroup": 5,
    "patientweight": null,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Myelosuppression",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "HERCEPTIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "B4902B04",
        "drugstructuredosagenumb": 600.0,
        "drugstructuredosageunit": "003",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Powder injection",
        "drugadministrationroute": "058",
        "drugindication": "Invasive breast carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-23T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-23T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "TRASTUZUMAB"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "DOCETAXEL",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "250122186",
        "drugstructuredosagenumb": 110.0,
        "drugstructuredosageunit": "003",
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        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Injection",
        "drugadministrationroute": "042",
        "drugindication": "Invasive breast carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-23T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-23T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "DOCETAXEL"
        },
        "drugrecurrence": []
      },
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CARBOPLATIN",
        "drugauthorizationnumb": null,
        "drugbatchnumb": "4L0436B01",
        "drugstructuredosagenumb": 0.4,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": null,
        "drugcumulativedosageunit": null,
        "drugdosagetext": null,
        "drugdosageform": "Powder injection",
        "drugadministrationroute": "042",
        "drugindication": "Invasive breast carcinoma",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-09-23T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-09-23T00:00:00",
        "drugtreatmentduration": null,
        "drugtreatmentdurationunit": null,
        "drugrecurreadministration": null,
        "drugadditional": 3,
        "actiondrug": 5,
        "activesubstance": {
          "activesubstancename": "CARBOPLATIN"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250929"
  },
  "primarysource": {
    "reportercountry": "CN",
    "qualification": 3,
    "literaturereference": null
  },
  "primarysourcecountry": "CN",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "NMPACDR",
      "duplicatenumb": "3501021025896202501730"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "ROCHE"
  },
  "serious": 1,
  "seriousnesscongenitalanomali": null,
  "seriousnessdeath": null,
  "seriousnessdisabling": null,
  "seriousnesshospitalization": null,
  "seriousnesslifethreatening": null,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-18T00:00:00",
  "transmissiondateformat": "102"
}
                        

25967143 Type 1

Serious

CYCLOPHOSPHAMIDE

Report Version

1

Receive Date

10/28/2025

Receipt Date

10/28/2025

Transmission Date

01/17/2026

Primary Source Country

CN

Occurrence Country

CN

Reporter Country

CN

Reporter Qualification

Physician

Literature Reference

--

Company Number

--

Authority Number

CN-NMPACDR-6101131009743202500355

Sender Organization

BAXTER

Sender Type

6

Receiver Organization

FDA

Receiver Type

6

Expedite Criteria

Yes

Duplicate

1

FAERS Quarter

2025Q4

Source File

1_ADR25Q4.xml

Patient Age

59.0 yr

Patient Age Group

--

Patient Sex

Female

Patient Weight

55.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Dry mouth (v28.1) Recovering

Dysgeusia (v28.1) Recovering

Feeling hot (v28.1) Unknown

Drugs (1)

CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect

Route: 041 | Dosage: 0.9 G, QD | Form: Powder for solution for injection/infusion | Indication: Breast cancer female | Action: Unknown

Start: 10/01/2025 | End: 10/01/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown

Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251001

Report Duplicates (1)

Baxter: CN-Baxter-2025BTHA005707

Raw JSON (click to expand)

                            {
  "_id": "69974fab8e900fe3f48c4edc",
  "safetyreportid": "25967143",
  "authoritynumb": "CN-NMPACDR-6101131009743202500355",
  "companynumb": null,
  "duplicate": 1,
  "fulfillexpeditecriteria": 1,
  "occurcountry": "CN",
  "patient": {
    "patientonsetage": 59.0,
    "patientonsetageunit": 801,
    "patientagegroup": null,
    "patientweight": 55.0,
    "patientsex": 2,
    "reaction": [
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dry mouth",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Dysgeusia",
        "reactionoutcome": 2
      },
      {
        "reactionmeddraversionpt": "28.1",
        "reactionmeddrapt": "Feeling hot",
        "reactionoutcome": 6
      }
    ],
    "drug": [
      {
        "drugcharacterization": 1,
        "medicinalproduct": "CYCLOPHOSPHAMIDE",
        "drugauthorizationnumb": "012142",
        "drugbatchnumb": "4L711A",
        "drugstructuredosagenumb": 0.9,
        "drugstructuredosageunit": "002",
        "drugseparatedosagenumb": 1.0,
        "drugintervaldosageunitnumb": 1.0,
        "drugintervaldosagedefinition": 804,
        "drugcumulativedosagenumb": 0.9,
        "drugcumulativedosageunit": "002",
        "drugdosagetext": "0.9 G, QD",
        "drugdosageform": "Powder for solution for injection/infusion",
        "drugadministrationroute": "041",
        "drugindication": "Breast cancer female",
        "drugstartdateformat": "102",
        "drugstartdate": "2025-10-01T00:00:00",
        "drugenddateformat": "102",
        "drugenddate": "2025-10-01T00:00:00",
        "drugtreatmentduration": 1.0,
        "drugtreatmentdurationunit": 804,
        "drugrecurreadministration": null,
        "drugadditional": 3,
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        "activesubstance": {
          "activesubstancename": "CYCLOPHOSPHAMIDE"
        },
        "drugrecurrence": []
      }
    ],
    "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251001"
  },
  "primarysource": {
    "reportercountry": "CN",
    "qualification": 1,
    "literaturereference": null
  },
  "primarysourcecountry": "CN",
  "quarter": "2025Q4",
  "receiptdate": "2025-10-28T00:00:00",
  "receiptdateformat": "102",
  "receivedate": "2025-10-28T00:00:00",
  "receivedateformat": "102",
  "receiver": {
    "receivertype": 6,
    "receiverorganization": "FDA"
  },
  "reportduplicate": [
    {
      "duplicatesource": "Baxter",
      "duplicatenumb": "CN-Baxter-2025BTHA005707"
    }
  ],
  "reporttype": 1,
  "safetyreportversion": 1,
  "sender": {
    "sendertype": 6,
    "senderorganization": "BAXTER"
  },
  "serious": 1,
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  "seriousnesshospitalization": 2,
  "seriousnesslifethreatening": 2,
  "seriousnessother": 1,
  "source_file": "1_ADR25Q4.xml",
  "transmissiondate": "2026-01-17T00:00:00",
  "transmissiondateformat": "102"
}
                        