BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER MESH

    MDR report key: 2163530 · Received July 7, 2011

    Report

    Report Number
    MW5021301
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    August 15, 2003
    Report Date
    July 7, 2011
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BLADDER LIFT USING MEDICAL MESH. I NOTICED A SHARP PAIN IN THE PELVIC AREA DURING RECOVERY PERIOD. OVER TIME I HAVE HAD EXTREME PAIN DURING SEXUAL ACTIVITY. IT'S TO THE POINT THAT I CHOOSE NOT TO ENGAGE BECAUSE OF THE PAIN LEVEL. THIS HAS CAUSED A FEW ISSUES IN MY MARRIAGE. I ALSO NOTICED HAVING TO TILT MY PELVIS TO GET A GOOD STREAM WHILE URINATING. DATES OF USE: (B)(6) 2003 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: DROPPED BLADDER, BLADDER LEAKAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other