BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE PERMANENT STERILIZATION COILS

    MDR report key: 6794089 · Received August 11, 2017

    Report

    Report Number
    MW5071570
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    May 11, 2007
    Report Date
    July 28, 2017
    Manufacturer
    CONCEPTUS / BAYER AG
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE CAUSED ME A NUMBER OF HEALTH PROBLEMS DUE TO BEING 55% NICKEL (AN KNOWN TOXIN AND CARCINOGEN TO HUMAN BEINGS), AS WELL AS CONTAINING PET FIBERS. DOCUMENT NUMBER: I1770500A. REPORT NUMBER: 20170728-6FEBA-2147398604.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569839 ESSURE PERMANENT STERILIZATION COILS ESSURE PERMANENT STERILIZATION COILS HHS CONCEPTUS / BAYER AG

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR