BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE MYCROMESH BIOMATERIAL MESH

    MDR report key: 2202204 · Received August 8, 2011

    Report

    Report Number
    MW5021679
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 6, 2009
    Report Date
    July 30, 2011
    Manufacturer
    W.L. GORE AND ASSOCIATES
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT PROBLEM OR USE FAILURE ASSOCIATED WITH MESH INTENDED TO REPAIR ABDOMINAL/INCISIONAL HERNIA. FROM DAY ONE I COMPLAINED IT WASN'T RIGHT AND HAVE HAD CONTINUAL PAIN AND PROTRUSIONS FROM DEVICE(MESH). I CONTINUE TO HAVE SEVERE PAIN, HERNIA NOT REPAIRED, PHYSICAL DEFORMITY, DIGESTIVE PROBLEMS ETC. THE HERNIA WILL SOMETIMES PROTRUDE OVER THE AREAS I HAVE HAD PROBLEMS AND COMPLAINT ABOUT, CAUSING EXTREME PAIN AND DISCOMFORT AND HAVE TO PHYSICALLY PUSH THE TISSUE BACK INSIDE. THE MESH NOW NEEDS TO BE COMPLETELY REMOVED AND MY ABDOMEN AND HERNIA RE-REPAIRED. THIS IS A MAJOR SURGERY THAT WILL REQUIRE HOSPITALIZATION AND HEALING. SURGEON, PCP, AND RECONSTRUCTIVE SURGEON HAVE BEEN NOTIFIED OF PROBLEMS AND COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE MYCROMESH BIOMATERIAL MESH BIOMATERIAL MESH FTL W.L. GORE AND ASSOCIATES 05013824

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R| S