BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3733543 · Received March 24, 2014

    Report

    Report Number
    2530154-2014-00001
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    January 16, 2014
    Report Date
    March 24, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED CLOSED TRAUMA FROM A FALL TWO YEARS AGO. HE PRESENTED WITH EVENTRATION AT THE PRIOR REPAIR SITE. ABDOMINAL WALL HERNIA REPAIR SURGERY WAS PERFORMED WITH IMPLANTATION OF A 20 X 30CM XCM BIOLOGIC. POST-OPERATIVELY, THE PT PRESENTED WITH A HEMATOMA THAT WAS MANAGED CONSERVATIVELY. DURING THE THIRD WEEK POST-OPERATIVE, THE PT COMPLAINED OF ABDOMINAL PAIN. HE WAS TAKEN BACK TO SURGERY FOR EXPLORATION. THE ABDOMEN WAS WASHED. CULTURES WERE TAKEN. THE SURGEON OBSERVED DEFECTS IN THE MESH. THE PATIENT HAS SUBSEQUENTLY HAD SEVERAL ADDITIONAL SURGICAL PROCEDURES SINCE THE REVISION SURGERY. HOWEVER, NO DETAILS ARE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172906 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LG. ABDOM FTM DSM BIOMEDICAL 30012-32 A6360

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR