BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2222988 · Received August 20, 2011

    Report

    Report Number
    MW5021830
    Event Type
    Injury
    Date Received
    August 20, 2011
    Date of Event
    August 1, 2003
    Report Date
    August 19, 2011
    Manufacturer
    NA
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HYSTERECTOMY/PROLAPSE SURGERY. VAGINAL MESH WAS USED, THIS COULD QUITE POSSIBLY BE THE CAUSE OF NUMEROUS BLADDER INFECTIONS, (B)(6) AND MILD INCONTINENCE AND HYPERTENSION SINCE MY HYSTERECTOMY IN 2003, I HAVE HAD A BLADDER CANCER SCARE. I FEEL THIS MAY BE DUE TO THE MESH USED IN MY PROLAPSE SURGERY IN 2003.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention CURRENTLY TAKING NITROFUR - MACR 100 MCG| CURRENTLY TAKING PHENAZOPYRIDINE, 200 MCG, AND