BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOLD HEMOSHIELD

    MDR report key: 396063 · Received May 23, 2002

    Report

    Report Number
    MW1025128
    Event Type
    Death
    Date Received
    May 23, 2002
    Date of Event
    January 22, 2002
    Report Date
    May 22, 2002
    Manufacturer
    MEADEX COMPANY
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AORTIC ANEURYSM REPAIR WITH GOLD HEMOSHIELD, MEADEX CO. PT DEVELOPED DIC SYNDROME AND EXPIRED. FOLLOWING IMPLANT PT RECEIVED FLUORESCEIN DYE, BECAME HYPOTENSIVE, TREATED FOR ALLERGIC REACTION AND THEN DEVELOPED DIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD HEMOSHIELD AORTA BIFURCATED GRAFT DSY MEADEX COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death