BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE SLING

    MDR report key: 949012 · Received November 13, 2007

    Report

    Report Number
    1645337-2007-00021
    Event Type
    Injury
    Date Received
    November 13, 2007
    Report Date
    November 12, 2007
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VAGINAL EROSION, EXTRUSION, DEHISCENCE AND INFECTION ARE KNOW COMPLICATIONS ASSOCIATED WITH THE USE OF BOTH SYNTHETIC AND ANTILOGOUS/DONOR TISSUE PUB-VAGINAL SLINGS FOR TREATMENT OF URINARY INCONTINENCE, SURGICAL TECHNIQUE VARIABLES, AND A HISTORY OF PREVIOUS OR CONCURRENT UROGYNECOLOGY SURGICAL PROCEDURES CAN AFFECT THE RATE OF THIS OCCURRENCE. IN ADDITION, PRE-EXISTING CO-MORBIDITIES THAT AFFECT HEALING SUCH AS OBESITY, HYPERTENSION, IMMUNOSUPPRESSION, DIABETES, RECURRENT VAGINAL OR URINARY TRACT INFECTIONS, AND POST-MENOPAUSAL VAGINAL MUCOSAL CHANGES CAN CONTRIBUTE TO AN INCREASED INCIDENCE OF THESE EVENTS.

    Description of Event or Problem · 1

    THE PATIENT HAD AN OBTAPE SLING. SUBSEQUENTLY, THE PATIENT EXPERIENCED EROSION OF INTERNAL BODILY TISSUES AND VAGINAL WALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTAPE SLING TRANSOBTURATOR FTL MENTOR 93-4000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention