BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURAMATRIX

    MDR report key: 3054947 · Received April 4, 2013

    Report

    Report Number
    2249852-2013-00001
    Event Type
    Other
    Date Received
    April 4, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 22, 2013
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K040888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ONE WEEK POST OP, THE PT DEVELOPED A BLEED AND HAD TO BE BROUGHT BACK TO THE OPERATING ROOM WHERE THE PRODUCT APPEARED "SHRIVELED" AND PROVIDED NO BARRIER. REVISION SURGERY WAS PERFORMED. THE PRODUCT WAS USED IN THE CHIARI REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137565 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE GXQ COLLAGEN MATRIX, INC. CDSM22 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention