BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGARD

    MDR report key: 3243367 · Received July 8, 2013

    Report

    Report Number
    3243367
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 3, 2013
    Manufacturer
    TEVA PHARMACEUTICAL
    Product Code
    HDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO OFFICE WITH (B)(4) PARAGARD IUD IN SITU REQUESTING TO HAVE IUD REMOVED AS SHE HAD BECOME PREGNANT AND WISHES TO TERMINATE PREGNANCY. IUD REMOVED WITH MODERATE AMOUNT TRACTION AND FOUND TO HAVE MISSING CROSS ARM, PATIENT HAD SMALL AMOUNT OF BLEEDING THEN STOPPED QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312337 PARAGARD PARAGARD 380A HDT TEVA PHARMACEUTICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention