BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISOVUE 370

    MDR report key: 563792 · Received September 29, 2004

    Report

    Report Number
    563792
    Event Type
    Death
    Date Received
    September 29, 2004
    Date of Event
    September 11, 2004
    Report Date
    September 29, 2004
    Manufacturer
    BRACCO DIAGNOSTICS, INC.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH GANGRENE OF TOE AND HISTORY OF DIABETES ADMITTED FOR AMPUTATION. CT, COMPUTERIZED TOMOGRAPHY, WITH CONTRAST VIA AUTO INJECTOR. PATIENT RECEIVED 180 CC OF CONTRAST,ISOVUE 370, EXPIRATION DATE 4/07. AFTER COMPLETION OF PROCEDURE PATIENT EXPERIENCED "SEIZURE LIKE ACTIVITY". CODE CALLED, PATIENT BRIEFLY REGAINED CONSCIOUSNESS AND SPOKE AND THEN LOST CONSCIOUSNESS AGAIN. UNABLE TO RESUSCITATE PATIENT AND THEY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOVUE 370 CONTRAST MEDIA IZQ BRACCO DIAGNOSTICS, INC. * 4D49817
    2 STELLANT CONTRAST INJECTOR IZQ MEDRAD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death