BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAMATRIX

    MDR report key: 4080190 · Received August 11, 2014

    Report

    Report Number
    2249852-2014-00005
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 30, 2014
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS ATTEMPTING TO CLOSE THE DURA USING DURAMATRIX AFTER ADDRESSING A CHIARI MALFORMATION, THE GRAFT TORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475768 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM33 1306283022

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention