BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX

    MDR report key: 2359088 · Received November 22, 2011

    Report

    Report Number
    2249852-2011-00002
    Event Type
    Other
    Date Received
    November 22, 2011
    Date of Event
    October 4, 2011
    Report Date
    November 20, 2011
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM33 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention