BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORETEX

    MDR report key: 1881893 · Received October 19, 2010

    Report

    Report Number
    MW5017855
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    March 10, 2009
    Report Date
    October 19, 2010
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABDOMINAL SURGERY FOR INCISIONAL HERNIA. I HAVE EXPERIENCED SWELLING, CHRONIC PAIN AND STOMACH DISTENTION. I HAVE A HARD TIME GOING TO THE BATHROOM NOW. MY REGULAR GP HAS ME TAKE VALIUM FOR BOWEL MOVEMENTS. I HAVE SHARED THIS INFO WITH MY DOCTOR AND OTHER DOCTORS, AND THEY SEEM TO THINK THERE IS NO PROBLEM, BUT I FEEL AWFUL. I CAN'T BEND OR DO DAILY TASKS SUCH AS DRESSING MYSELF. IT WAS GORETEX DUAL MESH THAT WAS PLACED INSIDE ME. DATES OF USE: (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORETEX DUAL MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention