BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTAPE

    MDR report key: 812311 · Received January 18, 2007

    Report

    Report Number
    1645337-2007-00001
    Event Type
    Injury
    Date Received
    January 18, 2007
    Report Date
    January 18, 2007
    Manufacturer
    MENTOR
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    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

    PATIENT EXPERIENCED AN INFECTED TRANSOBTURATOR. THE DEVICE WAS SUBSEQUENTLY REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention