BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2163529 · Received July 8, 2011

    Report

    Report Number
    MW5021298
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    August 7, 2003
    Report Date
    July 8, 2011
    Manufacturer
    UNK
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DUE TO (B)(6), HAD SURGERY TO PUT IN A "BLADDER SLING" / TRANSVAGINAL MESH ON (B)(6), 2003. THE MESH CAME THROUGH THE VAGINAL WALL REQUIRING SURGERY ON (B)(6) 2003. THE MESH CAME THROUGH THE VAGINAL WALL A SECOND TIME REQUIRING SURGERY ON (B)(6) 2004 (REMOVAL). ANOTHER SURGERY IN (B)(6) 2004 TO SEE IF ANY MESH COULD BE FOUND. HAVE BEEN IN CONSTANT CHRONIC PAIN SINCE BLADDER SLING PUT IN. MANY MEDICAL PROBLEMS, QUALITY OF LIFE IS POOR. WAS NOT AWARE (UNTIL RECENTLY) THAT THERE WERE MANY WOMEN HAVING PROBLEMS WITH THIS MESH PRODUCT. ALL THESE YEARS, I HAVE THOUGHT THAT MY BODY REJECTED THE MESH AND I WAS ALONE WITH THESE PROBLEMS. WOULD HAVE REPORTED THIS YEARS AGO, HOWEVER, I JUST FOUND OUT ABOUT THE FDA WARNINGS AND OTHER WOMEN COMPLAINING ABOUT THEIR MEDICAL PROBLEMS BECAUSE OF THIS MESH. BRAND NAME: INFO NOT FOUND IN MEDICAL RECORDS. MFR NAME: INFO NOT IN MEDICAL RECORDS OBTAINED FROM DOCTOR - AWAITING HOSPITAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TVT, TRANSVAGINAL TAPE, BLADDER SLING, TVT MESH FTL UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention| S