BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARC

    MDR report key: 2171297 · Received July 15, 2011

    Report

    Report Number
    MW5021404
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    May 19, 2005
    Report Date
    July 15, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CANNOT HAVE INTERCOURSE WITHOUT SEVERE PAIN, SO I HAVE NOT HAD INTERCOURSE FOR 6 YRS. HAVE SHARP KNIFE LIKE PAIN IN VAGINA. I HAVE A HUGE BULGE ON THE LEFT SIDE OF VAGINA. I HAVE TERRIBLE ITCHING AND FOUL ODOR FROM TIME TO TIME. UROLOGY DR CONTINUES TO SAY EVERY TIME I HAVE 6 MONTH CHECK UP THAT EVERYTHING LOOKS GOOD IN SURGICAL AREA. THEN WHY AM I IN SUCH PAIN. I HAD A SMALL LEAKAGE OF URINE NOW I HAVE ACCIDENTS WHERE I WENT THRU THE DEPENDS THAT I HAVE TO WEAR EVERYDAY. I AM VERY, VERY DEPRESSED FROM ALL THIS. UROLOGY DR GAVE ME FEMALE HORMONE JELLY AND THAT NEVER HELPED AT ALL. DIAGNOSIS OR REASON FOR USE: #1: URINARY INCONTINENCE. #2: FALLEN BLADDER AND PELVIC FLOOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARC BLADDER SLING FTL AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention