BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON TVT-O

    MDR report key: 1884930 · Received October 27, 2010

    Report

    Report Number
    MW5017908
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STARTED HAVING PROBLEMS IMMEDIATELY AFTER IMPLANT. INFECTIONS LASTED 5-6 MONTHS. PT NOT INFORMED OF RISKS. PT LEFT WITH SEVERE NERVE DAMAGE IN PELVIS AND DOWN BOTH LEGS. SEXUAL INTERCOURSE IS PAINFUL. CYSTOCELE DEVELOPED AND THERE IS POSSIBLE PELVIC EROSION. PT CANNOT SIT FOR MORE THAN 30 MINUTES AND IS BASICALLY HOME BOUND BECAUSE OF THIS. THERE HAS BEEN LITTLE IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON TVT-O TRANSVAGINAL TAPE FTL ETHICON 3270027

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other