BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MESH

    MDR report key: 2250690 · Received September 12, 2011

    Report

    Report Number
    MW5022243
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    September 26, 2008
    Report Date
    September 12, 2011
    Manufacturer
    UNKNOWN
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, I HAD A VAGINAL PROLAPSE AND BLADDER SUSPENSION DONE WITH SURGICAL MESH. I WAS RELEASED FROM THE HOSPITAL THE NEXT DAY WITH A CATHETER BECAUSE I COULDN'T PASS MY URINE. AFTER A WEEK WITH THE CATHETER, IT WAS REMOVED ONCE AGAIN AND I STILL COULDN'T PASS MY URINE. I WAS OPERATED ON AGAIN TO LOOSEN THE MESH AND I WAS DISCHARGED WITH THE CATHETER AGAIN FOR 5 DAYS. AFTER ABOUT A WEEK, I DEVELOPED A VERY BAD YEAST INFECTION FROM ALL THE ANTIBIOTICS. FOR OVER A YEAR, I WAS TREATED ALMOST EVERY 6 WEEKS FOR A URINARY TRACT INFECTION AND THEN YEAST INFECTIONS FROM THE ANTIBIOTICS. AFTER ABOUT A YEAR OF THE MESH BEING IMPLANTED, I BEGAN TO HAVE PAINFUL INTERCOURSE AND SPOTTING (HYSTERECTOMY IN 2000). DR. SAID I HAD EXPOSED MESH. HE REMOVED THE EXPOSED MESH AND I WAS OK FOR AWHILE. ABOUT A YEAR AGO, I BEGAN HAVING PAINFUL INTERCOURSE AGAIN AND SPOTTING. MY GYN DOES NOT DO THE MESH SURGERY BUT SAID THAT HE COULD SEE EXPOSED MESH ON EXAMINATION. HE SENT ME TO A SPECIALIST WHO SAID SHE COULD NOT SEE THE MESH AND GAVE ME A VERY PAINFUL EXAM. MY REGULAR GYN WOULD LIKE ME TO SEE A DOCTOR WHO IS TOP IN THE FIELD FOR THIS PROCEDURE IN MY AREA BUT MY INSURANCE DOES NOT COVER IT. SO NOW EVERY DAY, I LIVE WITH SPOTTING AND HAVE VIRTUALLY NO SEX LIFE ANYMORE BECAUSE IT IS TOO PAINFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other