BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX

    MDR report key: 1184696 · Received October 1, 2008

    Report

    Report Number
    2249852-2008-00001
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    March 17, 2008
    Report Date
    September 29, 2008
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CSF LEAKAGE POST-OPERATIVELY. REVISION SURGERY REQUIRED TO TREAT LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM45 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention