BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 2449809 · Received February 2, 2012

    Report

    Report Number
    2530154-2012-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    December 21, 2011
    Report Date
    February 2, 2012
    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: THE DEVICE WAS RETURNED TO THE MFR MORE THAN ONE WEEK BEFORE THE COMPLAINT WAS SUBMITTED. THE DEVICE WAS RECEIVED IN A DECOMPOSED STATE, MAKING PHYSICAL EVAL IMPOSSIBLE. PHOTOGRAPHS TAKEN BY THE SURGEON ON THE DATE OF EXPLANT WERE REVIEWED.

    Description of Event or Problem · 1

    THE PT HAS HAD AN OPEN ABDOMEN FOR 3 MONTHS. THE ABDOMEN WAS INFECTED, POSITIVE FOR KLEIBSIELLA. ON (B)(6) 2011, THE ABDOMEN WAS THOROUGHLY IRRIGATED, XCM BIOLOGIC MESH WAS IMPLANTED TO BRIDGE A LARGE GAP, THE ABDOMEN WAS LEFT OPEN AND A WOUND VAC WAS PLACED. APPROX 24 TO 36 HOURS LATER, THE SURGEON NOTICED VISIBLE BOWEL UNDERNEATH THE WOUND VAC DRESSING. XCM BIOLOGIC MESH APPEARED PARTIALLY DEGRADED. THE SURGEON SUBSEQUENTLY REMOVED THE REMAINING XCM TISSUE AND IMPLANTED ANOTHER MESH (POSSIBLE HUMAN TISSUE) AND THE ABDOMEN WAS LEFT OPEN. SUBSEQUENTLY, THE PT HAD SPLIT THICKNESS SKIN GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCM BIOLOGIC TISSUE MATRIX BIOLOGIC SURGICAL MESH FTM KENSEY NASH CORP. XM106.2025S KN94249

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention