BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAGUARD

    MDR report key: 36118 · Received August 29, 1996

    Report

    Report Number
    36118
    Event Type
    Death
    Date Received
    August 29, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 29, 1996
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SUBOCCIPITAL CRANIOTOMY, C-1 LAMINECTOMY, AND DURAL GRAFT IN 6/96. IN 7/96, THE PT WAS READMITTED WITH A DIAGNOSIS OF RULE OUT ACSEPTIC MENINGITIS. CULTURE RESULTS WERE POSITIVE FOR ASPERGILLUS FUMIGATUS: THE PT DEVELOPED LIFE THREATENING COMPLICATIONS OF THIS INFECTION. DESPITE MAXIMUM MEDICAL AND SURGICAL THERAPIES, THE PT DIED ON 8/24/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGUARD Implant DURAL REPAIR PATCH GXQ BIO-VASCULAR, INC. * DGS-95H24-147

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death