BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCI PLUS

    MDR report key: 536493 · Received July 6, 2004

    Report

    Report Number
    536493
    Event Type
    Other
    Date Received
    July 6, 2004
    Date of Event
    May 14, 2004
    Report Date
    June 24, 2004
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONTRAST EXTRAVASATION WITH OMNIPAQUE 300. APPROX 100CC WAS INJECTED TO DELTOID SITE. PROCEDURES FOLLOWED FOR EXTRAVASATION. BIOMEDICAL ENGINEERING ASSESSMENT COMPLETED AND INJECTOR FOUND TO BE WORKING PROPERLY. HOWEVER, THERE IS NO PRESSURE ADJUSTMENT ON THIS UNIT. IT IS PRE-SET FOR 300 PSI (POUNDS PER SQUARE INCH) MAXIMUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCI PLUS DYE INJECTOR FOR SCANS DXT MEDRAD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other