BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 806648 · Received January 17, 2007

    Report

    Report Number
    2520313-2007-00002
    Event Type
    Death
    Date Received
    January 17, 2007
    Date of Event
    December 10, 2006
    Report Date
    January 17, 2007
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD SERVICE REPRESENTATIVE CHECKED INJECTOR WITH NO PROBLEMS FOUND. MEDRAD APPLICATIONS REPRESENTATIVE PERFORMED ADDITIONAL APPLICATIONS TRAINING.

    Description of Event or Problem · 1

    HOSPITAL REPORTED 2 - 3MLS OF AIR ON IMAGES. PATIENT EXPIRED. PATIENT WAS A "DO NOT RESUSCITATE" PATIENT. EARLIER IN THE DAY, THE PATIENT WAS INVOLVED IN A BICYCLE ACCIDENT AND IN BAD SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD CT INJECTOR CT INJECTOR DXT MEDRAD, INC. SCT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death