BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVISOFT BIOMESH

    MDR report key: 1212044 · Received October 24, 2008

    Report

    Report Number
    MW5008775
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    April 7, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AT THREE MONTHS FOLLOWING SURGERY FOR PELVIC ORGAN PROLAPSE, USING THE PELVISOFT BIOMESH, I BEGAN TO EXPERIENCE URINARY INCONTINENCE, WORSE THAN PRESURGERY, PAIN IN PELVIC AND LOWER BACK AREA, INCREASED INCIDENCE OF URINARY INFECTIONS, BOWEL AND BLADDER LOSS OF CONTROL, AND OTHERWISE MALAISE WAS REFERRED TO UROLOGIST BY MY SURGEON AND OB/GYN, TO THIS DATE, NO APPARENT REASON FOR MEDICAL PROBLEMS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PELVIC ORGAN PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELVISOFT BIOMESH NONE FTL BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other