BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATED XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 1963736 · Received December 22, 2010

    Report

    Report Number
    2530154-2010-00004
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: LOT RELEASE TESTING DATA WAS REVIEWED AND PHOTOGRAPHS OF THE REMOVED DEVICE WERE PROVIDED FOR REVIEW BY THE SURGEON FOR REVIEW. RESULTS: LOT RELEASE TESTING SHOWED THAT ALL ACCEPTANCE CRITERIA HAD PASSED.

    Description of Event or Problem · 1

    A PT HAD INCISIONAL HERNIA REPAIR WITH IMPLANTATION OF A 20 X 30 CM XCM BIOLOGIC SURGICAL MESH TO BRIDGE A LARGE ABDOMINAL WALL DEFECT. NINE DAYS LATER, WHILE IN THE CLINIC WAITING ROOM FOR A FOLLOW-UP VISIT, THE MESH FAILED RESULTING IN EVISCERATION. ON (B)(6) 2010, THE XCM BIOLOGIC SURGICAL MESH WAS REMOVED. THE SURGEON FOUND THAT THE SUTURES HAD TORN THROUGH THE MESH ON THE RIGHT SIDE, BUT WERE INTACT ON THE LEFT SIDE. THERE WERE NO SIGNS OF INFECTION OR SEROMA. THE HERNIA SITE WAS SUBSEQUENTLY REPAIRED WITH A SYNTHETIC SURGICAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRATED XCM BIOLOGIC TISSUE MATRIX FTM - SURGICAL MESH FTM KENSEY NASH CORP. 30010-32 92486

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROLENE SUTURE| CT1 NEEDLE