BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR OBTAPE

    MDR report key: 1060640 · Received June 10, 2008

    Report

    Report Number
    MW5007284
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    December 21, 2004
    Report Date
    June 10, 2008
    Manufacturer
    MENTOR CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MENTOR OBTAPE WAS IMPLANTED IN ME FOR THE USE OF STRESS URINARY INCONTINENCE. INITIALLY IT WORKED, HOWEVER IN THE PAST 2+ YEARS THE PRODUCT HAS DISINTEGRATED INTO SMALLER PIECES, MIGRATED THROUGH MY LOWER BODY, CAUSED VAGINAL EROSION -X3 THUS FAR, CAUSED MASSIVE INFECTIONS, BLEEDING, PAIN AND EROSION. SEVERAL HOSPITAL TRIPS TO THE EMERGENCY ROOM AND MANY VISITS TO MY DOCTOR TO EXCISE THE DEFECTIVE PRODUCT. IT HAS CAUSED SUCH PAIN, BLEEDING AND INFECTIONS THAT INTERCOURSE WITH MY HUSBAND OF MANY YEARS IS NON-EXISTENT, THEREFORE WE HAVE A GREAT LOSS OF CONSORTIUM. THE PRODUCT STOPPED WORKING AS INTENDED - FOR SUI- JUST PRIOR TO HAVING THE FIRST MIGRATING PIECE EXCISED. THE INITIAL PROBLEM STILL EXISTS, IN ADDITION TO THE CONTINUING PROBLEMS, I NOW HAVE FROM THIS DEFECTIVE PRODUCT. DATES OF USE: 2004 - 2008. DIAGNOSIS OR REASONS FOR USE: STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR OBTAPE MENTOR OBTAPE FTL MENTOR CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S