BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVT

    MDR report key: 3121577 · Received May 10, 2013

    Report

    Report Number
    3121577
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    FAILED VAGINAL MESH. RECURRENT STRESS URINARY INCONTINENCE AFTER TENSION-FREE VAGINAL TAPE, PELVIC PAIN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TVT PLACEMENT FOR RECURRENT STRESS URINARY INCONTINENCE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207662 GYNECARE TVT MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. * 3428644

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR