BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT-SYSTEM PELVIC ANT FLOOR REPAIR

    MDR report key: 2240763 · Received September 2, 2011

    Report

    Report Number
    MW5022142
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    February 9, 2006
    Report Date
    September 2, 2011
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2006, HAD SURGERY FOR CYSTOCELE, MIDLINE, DURING SURGERY MY BLADDER WAS LACERATED. PROLIFT WAS IMPLANTED AND MY LIFE TOTALLY CHANGED. TWO DAYS BEFORE I WAS VERY ABLE TO HAVE INTERCOURSE WITH MY HUSBAND AND WE HAVE NOT BEEN ABLE TO HAVE INTERCOURSE AT ALL, NOT ONCE SINCE 2006. I HAVE PAIN, SOMETIMES EXTREME, CRAMPING, URINARY PROBLEMS, MESH EROSION, VAGINAL ATROPHY, ETC, AND IT IS VERY DEPRESSING, CAN'T EXERCISE BECAUSE OF PAIN AND CRAMPING, SCARRING. DR SUGGESTED SURGERY TO TRY AND CLEAN UP SOME SCARRING AND LOOSEN STRAPS OF PROLIFT, BUT WAS NOT ENCOURAGING ABOUT THE RESULTS. SAID IT COULD CAUSE MORE DAMAGE AND ABSOLUTELY NO GUARANTEE. PLEASE, I JUST WANT MY OLD LIFE BACK. I WAS ALSO TOLD PROLIFT CANNOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT-SYSTEM PELVIC ANT FLOOR REPAIR PELVIC FLOOR REPAIR FTL JOHNSON AND JOHNSON PFRA01 0362894

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR