BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVAGINAL MESH

    MDR report key: 2240772 · Received September 2, 2011

    Report

    Report Number
    MW5022126
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 10, 2005
    Report Date
    September 2, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TRANSVAGINAL MESH INSERTED FOR URINARY INCONTINENCE. A FEW DAYS LATER, I EXPERIENCED EXCRUCIATING PELVIC PAIN AND HAD TO RETURN TO MY GYN WHO DID THE SURGERY, - PLACEMENT. SHE INJECTED UNK NUMBING MEDS TO RELIEVE THE PAIN. THEN I STARTED HAVING INCREASED DIFFICULTY EVACUATING MY BOWELS, WHICH STILL REMAINS TODAY CAUSING INTERNAL AND EXTERNAL HEMORRHOIDS. I AM NOT ABLE TO CONTROL MY URINE, AND CANNOT COMPLETELY EMPTY MY BLADDER, CAUSING UTI'S AND CYSTITIS. I SOMETIMES HAVE EITHER A YELLOWISH AND A DARK-TEA COLORED DRAINAGE. I HAVE LOWER ABDOMINAL PAIN AND SORENESS WHILE VACUUMING OR DOING OTHER BENDING/STOOPING HOUSE WORK. MY GASTROENTEROLOGIST STATED THAT THE MESH IMPEDES BOWEL MOVEMENTS. MY GYN STATED THE MESH WOULD BE TOO ENTAILED TO REMOVE. I DO NOT KNOW THE NAME OR MANUFACTURER OF THE MESH. I URGE THE PLACING OF TRANSVAGINAL MESH BE ELIMINATED. ALONG WITH THE MESH PLACEMENT, I ALSO HAD A RECTOCELE AND A CYSTOCELE FOR PROLAPSED ORGANS, WHICH I AM SURE BY NOW HAVE RETURNED, AND ADDS TO MY DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVAGINAL MESH TRANSVAGINAL MESH FTL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O| R