BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX

    MDR report key: 1520504 · Received October 30, 2009

    Report

    Report Number
    2249852-2009-00005
    Event Type
    Other
    Date Received
    October 30, 2009
    Date of Event
    April 15, 2009
    Report Date
    May 20, 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
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED REVISION SURGERY 6 WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM22 0812303022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention