BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE BIO-A TISSUE REINFORCEMENT

    MDR report key: 2842064 · Received November 12, 2012

    Report

    Report Number
    3003910212-2012-00034
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K033671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS AND WAS STERILIZED PER PROCEDURE. A PORTION OF THE PRODUCT HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING EXAMINATION. ALL INFO HAS BEEN MADE AVAILABLE FOR TRACKING, TRENDING AND F/U.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PT UNDERWENT INCISIONAL HERNIA REPAIR WITH GORE BIO-A TISSUE REINFORCEMENT. DURING THE PROCEDURE, THE PT ALSO HAD A GI FISTULA REPAIRED AND CUT POUCH ILEOSTOMY TAKE DOWN. APPROX ONE WEEK POST OPERATIVE, THE PT EXPERIENCED MILKY WHITE DISCHARGE COMING FROM THE SURGICAL WOUND. A SECOND PROCEDURE WAS PERFORMED IN WHICH THE WOUND WAS DEBRIDED AND FRAGMENTS OF GORE BIO-A TISSUE REINFORCEMENT WERE REMOVED AND SENT FOR PATHOLOGICAL EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE BIO-A TISSUE REINFORCEMENT FTL / MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES 10185966

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention