BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 3192696 · Received May 2, 2013

    Report

    Report Number
    1018233-2013-01587
    Event Type
    Other
    Date Received
    May 2, 2013
    Report Date
    April 8, 2013
    Product Code
    FTL
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PT HAS EXPERIENCED URINARY INCONTINENCE WITH URGE AND STRESS INCONTINENCE, EXTRUDED MESH FROM LEFT VAGINAL WALL, RECURRENT VAGINAL PROLAPSE, ANTERIOR VAGINAL WALL EROSION, POSTERIOR VAGINAL AND MID RIGHT POSTERIOR VAGINAL WALL, DIFFICULTY EMPTYING BLADDER, PELVIC FLOOR LAXITY, LOSS OF BOWEL FULLNESS SENSATION, LOSS OF BOWEL CONTROL, ALTERNATING LOOSE STOOL AND CONSTIPATION, AND RECTOCELE. REFERENCE MFR REPORT # 9615742-2013-00341.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193608 NONE FTL SFL00144

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR