BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIRAY (IOVERSOL) 350

    MDR report key: 1131168 · Received August 19, 2008

    Report

    Report Number
    1131168
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 18, 2008
    Product Code
    KTA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT GIVEN IV CONTRAST IN PREPARATION FOR CT SCAN. PT EXPERIENCED ALLERGIC REACTION INCLUDING SWELLING, NAUSEA, HYPOTENSION AND BREATHING DIFFICULTY. DOSE, FREQUENCY & ROUTE USED: 125ML; 1 DOSE, INTRAVENOUS. DIAGNOSIS FOR USE: CT SCAN, RADIOPAQUE AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIRAY (IOVERSOL) 350 NONE KTA P186B

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R