BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX

    MDR report key: 905513 · Received March 13, 2007

    Report

    Report Number
    2249852-2007-00001
    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

    ALL LOTS OF DURAMATRIX UNDERGO PHYSICOCHEMICAL AND MECHANICAL TESTING, AND THE TEST RESULTS MUST PASS THE RELEASE CRITERIA IN ORDER FOR THE PRODUCTS TO BE DISTRIBUTED.ALL LOTS OF DURAMATRIX UNDERGO PHYSICOCHEMICAL AND MECHANICAL TESTING, AND THE TEST RESULTS MUST PASS THE RELEASE CRITERIA IN ORDER FOR THE PRODUCTS TO BE DISTRIBUTED.

    Description of Event or Problem · 1

    A CSF LEAK WAS FOUND IN THE OUTER STITCHING OF THE WOUND. 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. CDSM33 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention