BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAMATRIX-ONLAY

    MDR report key: 2088274 · Received May 12, 2011

    Report

    Report Number
    2249852-2011-00001
    Event Type
    Death
    Date Received
    May 12, 2011
    Date of Event
    March 1, 2010
    Report Date
    May 3, 2011
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K061487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 2 ASSOCIATED WITH THIS DEVICE. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INITIAL PROCEDURE ON (B)(6) 2010, FOR CANCER METASTASIS AND RE-ADMITTED ON (B)(6) 2010, FOR CEREBROSPINAL FLUID LEAK. LEAK COVERED WITH SURGICAL AND FIBRIN GLUE. PATIENT DIED SECONDARY TO BRAINSTEM HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX-ONLAY COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSLM45 0907233022

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death