BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLIFORM GRAFT

    MDR report key: 1210969 · Received October 23, 2008

    Report

    Report Number
    MW5008755
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    June 17, 2008
    Report Date
    October 23, 2008
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD A LAV HYSTERECTOMY AND TOTAL PELVIC FLOOR RECONSTRUCTION WHICH CONSISTED OF A CYSTOCELE, RECTOCELE AND ENTEROCELE USING THE REPLIFORM GRAFT TO REPAIR PELVIC ORGAN PROLAPSE AND SUI. I ALSO HAD A SLING PLACED UNDER MY BLADDER AND REPAIR TO MY URETHRAL SPHINCTER. TWO WEEKS LATER, I BECAME INCONTINENT AND WAS EVENTUALLY DIAGNOSED WITH A VESICOVAGINAL FISTULA. I BELIEVE THAT AT SOME POINT, DURING THE PROCEDURES, THAT SOMEONE PERFORATED MY BLADDER WHICH LED TO THE EROSION THROUGH MY VAGINAL WALL AND SUBSEQUENT URINARY INCONTINENCE. NOW URINE ONLY FLOWS OUT MY VAGINA - NOTHING HAS PASSED THROUGH MY URETHRA FOR 4 MONTHS NOW-. I AM SCHEDULED FOR A REPAIR SURGERY IN 2008 AND AM HOPING THAT THIS CURRENT SITUATION IS NOT PERMANENT. DATES OF USE: STILL IN ME. DIAGNOSIS OR REASON FOR USE: PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLIFORM GRAFT NONE FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| S