BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE BIOABSORBABLE HERNIA PLUG

    MDR report key: 2211292 · Received August 3, 2011

    Report

    Report Number
    3003910212-2011-00014
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 4, 2011
    Report Date
    August 2, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K033671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNAVAILABLE, THEREFORE DIRECT PRODUCT ANALYSIS AND REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THE POTENTIAL FOR SUCH EVENTS IS ADDRESSED IN THE PRODUCT'S INSTRUCTIONS-FOR-USE WHICH STATES, "POSSIBLE ADVERSE REACTIONS MAY INCLUDE, BUT ARE NOT LIMITED TO, INFECTION, INFLAMMATION, ADHESIONS AND SEROMA FORMATION." ALL INFORMATION HAS BEEN MADE AVAILABLE FOR TRACKING AND TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH THE GORE BIO-A HERNIA PLUG AND FIVE DAYS POST OPERATIVE, PRESENTED WITH A SMALL BOWEL OBSTRUCTION. IT WAS OBSERVED DURING A SECOND PROCEDURE THAT BOWEL WAS ADHERED TO THE HERNIA PLUG AND A PIECE OF THE PLUG'S DISC HAD SEPARATED. THE SURGEON LET DOWN THE BOWEL AND PLACED A MESH OVER THE HERNIA PLUG. THE HERNIA PLUG REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL DETAILS FROM THE SURGEON HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE BIOABSORBABLE HERNIA PLUG FTL / MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES WLG530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention