BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERNIA REPAIR MESH

    MDR report key: 2220453 · Received August 17, 2011

    Report

    Report Number
    MW5021809
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    January 10, 2009
    Report Date
    August 17, 2011
    Manufacturer
    GORE
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN RT INGUINAL HERNIA REPAIR 30 YR AGO WITH SUTURES. THREE YRS AGO, I HAD A LEFT INGUINAL HERNIA REPAIR WITH POLYPROPYLENE MESH. LAST YR I HAD A BIOPSY OF A LYMPH NODE NEAR THE MESH. THE BIOPSY SHOWED NHL. COULD THE NHL BE A REACTION TO THE MESH? SINCE HERNIA REPAIR IS THE MOST COMMON OPERATION IN THE (B)(6), AND NHL IS NUMBER 6 CANCER OCCURRENCE, IS THERE ANY CORRELATION OF THE TWO? ALSO, WOULD IT BE WISE TO HAVE THE MESH REMOVED?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERNIA REPAIR MESH HERNIA REPAIR MESH FTL GORE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other