BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH GYNECARE PROLIFT

    MDR report key: 7600517 · Received June 13, 2018

    Report

    Report Number
    MW5077829
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    November 18, 2011
    Report Date
    June 12, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD THIS PRODUCT PUT IN 2008 TRANSVAGINAL MESH, HAD PROBLEMS ALL ALONG BUT (B)(6) BLEEDING PAIN, LOSS OF WORK, CONSORTIUM, FAMILY LIFE. (B)(6) TOOK MESH OUT AND A 2HR SURGERY TURNED INTO 7HRS MESH TORE MY UTERAL TUBE WHICH HAD TO BE RECONSTRUCTED. IT CAUSED NERVE DAMAGE. I HAD 1 UNIT OF BLOOD AND MANY OTHER PROBLEMS. I HAVE BEEN MARRIED 31 YEARS NOW KIND OF SHAKY. BEEN IN COURT ROOM FOR 6 YEARS NOW NO RELIEF IN SIGHT. I CAN NO LONGER AFFORD HEALTH INSURANCE. I QUIT TAKING ALL MEDICINE. I JUST TAKE A DAY AT A TIME. I HAVE PRESENTLY NERVE DAMAGE, MYOFASCIAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439950 TRANSVAGINAL MESH GYNECARE PROLIFT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. PFRAO1 3135683

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R| S