BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 1581012 · Received January 15, 2010

    Report

    Report Number
    1121308-2010-00003
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    August 31, 2009
    Report Date
    January 15, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS REQUESTED ADD'L CLINICAL INFO FROM THE REPORTER. THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IN 2004 - DURAGEN GRAFT FOR CSF LEAK FOLLOWING SPINAL SURGERY. IN 2009 - DEVELOPED DIFFUSE ENCEPHALOPATHY. RAPID DETERIORATION TO DEATH IN 3 WEEKS. PROTEIN 14-3-3+VE. PRESUMPTIVE CJD. PM AWAITED. BATCH NUMBER NOT RECORDED ON NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death NOT PROVIDED