BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX

    MDR report key: 906005 · Received March 13, 2007

    Report

    Report Number
    2249852-2007-00002
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 9, 2007
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION INCLUDED REVIEW OF COMPLETE DEVICE HISTORY RECORD AND VISUAL ASSESSMENT OF REVERSE PRODUCT FROM THE SAME LOT. ALL IN-PROCESS AND FINISHED PRODUCT TEST RESULTS PASSED THE RELEASE CRITERIA. VISUAL ASSESSMENT OF THE RESERVE PRODUCT WAS ACCEPTABLE.

    Description of Event or Problem · 1

    A CSF LEAK WAS FOUND. A LUMBAR DRAIN WAS PLACED, BUT REVISION SURGERY WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM11 0604044022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention