BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH BIOMATERIAL

    MDR report key: 2722220 · Received August 28, 2012

    Report

    Report Number
    2017233-2012-00579
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    July 1, 2005
    Report Date
    August 5, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K992189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GORE HAS REQUESTED ADDITIONAL INFORMATION FROM THE AUTHOR. ADAM KOLKER, DANIEL J. BROWN ET AL. MULTILAYER RECONSTRUCTION OF ABDOMINAL WALL DEFECTS WITH ACELLULAR DERMAL ALLOGRAFT (ALLODERM) AND COMPONENT SEPARATION ANNALS OF PLASTIC SURGERY 2005; 55-36-42.

    Description of Event or Problem · 1

    REVIEW OF JOURNAL ARTICLE ENTITLED, "MULTILAYER RECONSTRUCTION OF ABDOMINAL WALL DEFECTS WITH ACELLULAR DERMAL ALLOGRAFT (ALLODERM) AND COMPONENT SEPARATION" REVEALED THAT A PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH GORE DUALMESH BIOMATERIAL AND DEVELOPED PURULENT DRAINAGE FROM THE WOUND SIX MONTHS POST OPERATIVE. THE MESH WAS REMOVED AND THE INFECTION WAS DRAINED. THE WOUND WAS DEBRIDED, LAVAGED AND A SUBATMOSPHERIC PRESSURE DRESSING WAS APPLIED FOR ONE WEEK. THE PATIENT UNDERWENT A SECOND PROCEDURE AND WAS WITHOUT RECURRENCE AT 18 MONTHS WITH DYNAMIC ABDOMINAL WALL FUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention