BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 7888644 · Received September 19, 2018

    Report

    Report Number
    2530154-2018-00005
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    July 6, 2018
    Report Date
    September 17, 2018
    Manufacturer
    DSM BIOMEDICAL INC.
    Product Code
    OXK
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE NATURE OF THE COMPLAINT, RAPID ABSORPTION OF THE DEVICE IS CURRENTLY CAPTURED APPROPRIATELY WITHIN DSM'S RISK ANALYSIS FOR THE XCM BIOLOGIC TISSUE MATRIX. A PRODUCT/PROCESS REVIEW WAS DEEMED AN APPROPRIATE TECHNIQUE FOR REVIEWING ALL PROCESS AND BATCH DATA TO ENSURE COMPLIANCE WITH THE PRODUCT REQUIREMENTS. THE BATCH RECORDS FOR THE LOT WERE REVIEWED, AND NO DISCREPANCIES WERE OBSERVED THAT WOULD HAVE NEGATIVELY IMPACTED THE PERFORMANCE OF THE DEVICE. EXISTING CONTROLS AND MITIGATIONS IN PLACE WERE REVIEWED IN (B)(4). UPON REVIEW OF THE RISK ASSESSMENT AND CURRENT CONTROLS IN PLACE, IT WAS DETERMINED THAT THE CONTROLS REFERENCED IN THE RISK ANALYSIS REMAIN ACCEPTABLE AND APPLICABLE AT THIS TIME. NO ASSIGNABLE ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) YEAR-OLD FEMALE WITH A BMI OF 32. ON THE (B)(6), XCM BIOLOGIC MESH WAS INSERTED AFTER A BOWEL RESECTION FOR PERITONITIS SECONDARY TO A SMALL BOWEL TEAR DURING A MASSIVE VENTRAL HERNIA REPAIR WITH PROGRESSIVE PNEUMOPERITONEUM. PATIENT HAD SEVERAL VACUUM ASSISTED CLOSURES (VAC) PERFORMED. DURING THE VAC ON (B)(6), IT WAS NOTED THAT THE XCM MESH HAD WEAKENED. DURING THE VAC ON THE (B)(6), IT WAS NOTED THAT THE RIGHT SIDE OF THE MESH HAD LIQUIFIED. DURING THE VAC ON THE (B)(6), IT WAS NOTED THAT THE XCM BIOLOGIC MESH HAD COMPLETELY DISAPPEARED. BRIDGING OF THE WOUND OCCURRED. THE DEVICE WAS INSERTED INTO AN AREA SUSPECTED OF BEING INFECTED BUT THE PATIENT DID NOT HAVE A FEVER, NOR WERE ANY BACTERIAL CULTURES OBTAINED. THE PATIENT WAS LEFT WITH AN OPEN ABDOMEN WITH ENTEROATHMOSPHERIC FISTULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731713 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL INC. 30013-30, -32 C8203, E8358

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization