BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCM BIOLOGIC TISSUE MATRIX

    MDR report key: 3893601 · Received June 9, 2014

    Report

    Report Number
    2530154-2014-00005
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 14, 2014
    Manufacturer
    DSM BIOMEDICAL
    Product Code
    FTM
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND REMAINS IN THE PATIENT. PHOTOGRAPHS WERE PROVIDED FOR REVIEW THAT DEMONSTRATE SMALL TEARS IN THE MESH. ALTHOUGH, IT CANNOT BE CONFIRMED FROM THE PHOTOGRAPHS AND FROM THE PROVIDED INFORMATION, OPERATIONAL CONTEXT (METHOD OR IMPLANTATION AND PATIENT COMORBIDITIES) MAY HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORDS FOR DSM LOT NUMBER A6366 WAS REVIEWED. THERE WERE NO DEVIATIONS RELATED TO THE AFFECTED MODE, ALL PRODUCT MET THE PRE-DETERMINED ACCEPTANCE CRITERIA. THERE ARE NO LIKE COMPLAINTS FOR DSM LOT NUMBER A6366. THE INTERMEDIATE PRODUCT LOTS CONTAIN IN LOT NUMBER A6366 HAVE NO LIKE FAILURE REPORTED IN OTHER UPPER LEVEL LOTS.

    Description of Event or Problem · 1

    THE PATIENT HAS A PAST MEDICAL HISTORY THAT INCLUDES MULTIPLE ABDOMINAL WALL REVISIONS. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH TOXIC MEGACOLON, DUODENUM FISTULAE AND ABDOMINAL FISTULAE. COLECTOMY WAS PERFORMED. XCM BIOLOGIC WAS IMPLANTED WITH SUTURE FOR ABDOMINAL WALL RECONSTRUCTION. IT WAS REPORTED THAT ON DAY 4 POST-OPERATIVE, MULTIPLE SMALL TEARS WERE OBSERVED IN THE MESH. ON DAY 7 POST-OPERATIVE, THE PATIENT RETURNED TO THE OPERATING THEATER. THE SMALL TEARS WERE REPAIRED AND AN ADDITIONAL XCM BIOLOGIC MESH WAS IMPLANTED TO REINFORCE THE REPAIR. AS OF THE DATE OF THIS REPORT, THE PATIENT'S CONDITION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334303 XCM BIOLOGIC TISSUE MATRIX MESH, SURGICAL, COLLAGEN, LG ABD WAL FTM DSM BIOMEDICAL A6366

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R