BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE DUALMESH BIOMATERIAL

    MDR report key: 2202333 · Received August 5, 2011

    Report

    Report Number
    3003910212-2011-00015
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    February 22, 2011
    Report Date
    August 4, 2011
    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

    METHOD: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNAVAILABLE, THEREFORE, A DIRECT PRODUCT ANALYSIS AND REVIEW OF MANUFACTURING RECORDS WAS NOT CONDUCTED. THE POTENTIAL FOR SUCH EVENTS IS ADDRESSED IN THE DEVICE'S INSTRUCTIONS-FOR-USE WHICH STATES, "POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY 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 AN EXPLORATORY LAPAROTOMY FOR PERSISTENT HIGH GRADE BOWEL OBSTRUCTION. LYSIS OF ADHESIONS AND A SMALL BOWEL RESECTION WAS PERFORMED AFTER ENTERING THE ABDOMEN THROUGH WELL INCORPORATED GORE DUALMESH BIOMATERIAL. GORE DUALMESH BIOMATERIAL HAD BEEN IMPLANTED EIGHT YEARS PRIOR FOR VENTRAL HERNIA REPAIR. NINE DAYS POST OPERATIVE; THE PT PRESENTED IN SEPTIC SHOCK. THERE WAS FECULENT WOUND DRAINAGE AND CT REVEALED EXPOSED GORE DUALMESH BIOMATERIAL AT THE BASE OF THE MIDLINE INCISION. THE PT WAS RESUSCITATED AND A WOUND VAC WAS APPLIED. SEVERAL DAYS LATER, THE MESH WAS REMOVED AND THE FASCIA WAS REAPPROXIMATED ALONG THE MIDLINE AND AN ONLAY REPAIR WAS PERFORMED. IT WAS REPORTED THAT THE PT'S RECOVERY WAS UNREMARKABLE AND THE INCISION HEALED WITHOUT COMPLICATION ONE MONTH AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DUALMESH BIOMATERIAL FTL / MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES WLG101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention