BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX

    MDR report key: 1373610 · Received May 2, 2009

    Report

    Report Number
    2249852-2009-00002
    Event Type
    Other
    Date Received
    May 2, 2009
    Date of Event
    January 8, 2009
    Report Date
    April 24, 2009
    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

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD PERFORMED. PRODUCT MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    DATE OF SURGERY WAS (B) (6) 2007. PATIENT NEEDED REVISION SURGERY 24 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM33 0607133022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention