BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH PLUS BIOMATERIAL

    MDR report key: 2202334 · Received August 8, 2011

    Report

    Report Number
    3003910212-2011-00016
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 8, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K063435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE PERFORMED. REVIEW OF THE MFG AND STERILIZATION RECORDS INDICATE THAT THE DEVICE MET ALL PRE-RELEASE SPECS. THE POTENTIAL FOR SUCH EVENTS IS INDICATED IN THE DEVICE'S INSTRUCTIONS-FOR-USE WHICH STATE, "POSSIBLE ADVERSE REACTIONS INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE." ALL INFO HAS BEEN MADE AVAILABLE FOR TRACKING AND TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PT UNDERWENT VENTRAL HERNIA REPAIR WITH GORE DUALMESH PLUS BIOMATERIAL AND TWO DAYS POST OPERATIVE DEVELOPED PAIN AND ELEVATED WBCS. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND A COLLECTION OF CLOUDY FLUID WAS OBSERVED. THE MESH WAS EXPLANTED AND A WASH OUT AND HERNIA REPAIR WERE PERFORMED. IT WAS REPORTED THAT CULTURES YIELDED NEGATIVE RESULTS AND THE PT WAS DOING MUCH BETTER THE DAY FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DUALMESH PLUS BIOMATERIAL FTL/MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES WLG106 8477033

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention