BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2202048 · Received August 6, 2011

    Report

    Report Number
    MW5021668
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Report Date
    August 6, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A HYSTERECTOMY AND INSTALLED BLADDER SLING DUE TO PROLAPSED ORGANS AND BLADDER LEAKAGE WHEN SNEEZING, COUGHING OR LAUGHING. AFTER HEALING, SEX WAS PAINFUL. I ASSUMED EVERYTHING HAD BEEN "TIGHTENED UP" TOO MUCH. WE HAVEN'T HAD INTERCOURSE FOR 6 YEARS BECAUSE IT WAS SO PAINFUL. WORSE PART THOUGH IS THAT I GET BLADDER INFECTIONS ABOUT EVERY 2 MONTHS NO MATTER WHAT I TRY TO DO TO PREVENT THEM. I AM GOING TO TALK TO MY DOCTOR AND SEE IF IT CAN BE REMOVED. I WOULD RATHER HAVE SOME LEAKAGE THAN CONSTANT INFECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1