BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX-ONLAY

    MDR report key: 2090845 · Received May 12, 2011

    Report

    Report Number
    2249852-2010-00002
    Event Type
    Other
    Date Received
    May 12, 2011
    Date of Event
    August 30, 2010
    Report Date
    October 31, 2010
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFECTION REQUIRING SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAMATRIX-ONLAY COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSLM33 0904243022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention