BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 5495033 · Received March 11, 2016

    Report

    Report Number
    2530154-2016-00006
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    January 28, 2016
    Report Date
    March 11, 2016
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    OXK
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS DOES NOT HAVE DEVIATIONS THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE PRODUCT MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA. REVIEW OF STERILIZATION RECORDS INDICATE THE PRODUCT WAS PROCESSED IN ACCORDANCE WITH PRODUCT REQUIREMENTS AND MET ALL PRE-DETERMINED ACCEPTANCE CRITERIA FOR STERILITY. THE CAUSE OF THE EVENT CAN NOT BE DETERMINED FROM THE PROVIDED INFORMATION OR THE MANUFACTURING RECORDS. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED IN A FOLLOW-UP REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT HAD XCM BIOLOGIC IMPLANTED AS PART OF AN UNKNOWN SURGICAL PROCEDURE IN THE ABDOMEN. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN ON THE THIRD POST-OPERATIVE DAY. UNKNOWN DIAGNOSTIC TESTS WERE PERFORMED THAT REVEALED ABDOMINAL EVENTRATION. ON THE FOURTH POST-OPERATIVE DAY, THE PATIENT WAS BROUGHT BACK TO THE OPERATING THEATER FOR REVISION. THE SURGEON OBSERVED SEVERAL SMALL HOLES IN THE MESH. THE MESH WAS EXPLANTED AND REPLACED WITH ANOTHER SURGICAL MESH. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150526 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS OXK DSM BIOMEDICAL XM106.2030S KNC1027

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention