BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-O 810081

    MDR report key: 7116559 · Received December 13, 2017

    Report

    Report Number
    MW5073958
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 9, 2009
    Report Date
    December 12, 2017
    Manufacturer
    ETHICON/ J AND J
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A GYNECARE TVT-O IMPLANTED. I'VE NOW HAD SEVERAL FISTULA SURGERIES, CONSTANT VAGINAL ABSCESSES, NERVE PAIN, COMPLETE INCONTINENCE AND NOW PIECES ARE COMING THROUGH MY SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891403 GYNECARE TVT-O 810081 MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON/ J AND J

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability