BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX

    MDR report key: 1278334 · Received December 23, 2008

    Report

    Report Number
    2249852-2008-00002
    Event Type
    Other
    Date Received
    December 23, 2008
    Date of Event
    August 29, 2008
    Report Date
    December 15, 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

    INFECTION WAS DETECTED POST-OPERATIVELY, AND PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM45 0712213022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention