BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAVIST

    MDR report key: 2662954 · Received July 16, 2012

    Report

    Report Number
    2662954
    Event Type
    Death
    Date Received
    July 16, 2012
    Date of Event
    July 3, 2012
    Report Date
    July 16, 2012
    Manufacturer
    BAYER HEALTHCARE PHARMACETICLES
    Product Code
    ---
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME IN WITH FEW DAY HISTORY OF ABDOMINAL PAIN, VOMITING, DIARRHEA AND FEVER. AFTER SCAN WITH CONTRAST WAS COMPLETED, COMPLAINED OF HEART RACING AND HARD TIME BREATHING. NO SWELLING, HIVES OR THROAT TIGHTNESS. SATS AT 100%. UNSURE IF REACTION TO CONTRAST DYE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVIST IOPROMIDE --- BAYER HEALTHCARE PHARMACETICLES * *
    2 STELLANT INJECTOR, CONTRAST DXT MEDRAD INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death