BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN DURAL GRAFT MATRIX

    MDR report key: 3190256 · Received June 21, 2013

    Report

    Report Number
    1121308-2013-00031
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    PMA / PMN Number
    K092388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    DURING A ROUTINE MEETING ON TUESDAY (B)(6) 2013, THE TOPIC OF THE RECENT DURAGEN RECALL WAS DISCUSSED. THIS HOSP HAS HISTORICALLY BEEN A LARGE DURAGEN ACCOUNT AND THE RECALL/BACK ORDER ISSUE AFFECTED THEM QUITE CONSIDERABLY. HOWEVER, SINCE THE ISSUES HAVE BEEN RESOLVED THE NEUROSURGEONS HAVE BEEN HAPPY TO RETURN TO USING OUR PRODUCTS ALTHOUGH HAD ASKED THE QUESTION OF WHY THE RECALL HAD HAPPENED IN THE FIRST INSTANCE. IT THEN CAME TO LIGHT THAT TWO OF THE NEUROSURGEONS - HAD RECENTLY HAD 4-5 PTS WHO HAD CONTRACTED POST SURGICAL CHEMICAL MENINGITIS. THEY ARE NOT SUGGESTING THAT DURAGEN WAS THE CAUSE OF THIS AND THEY HAVE STATED THEY DIDN'T THINK IT WAS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283197 DURAGEN DURAL GRAFT MATRIX NA GXQ INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1