BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 541913 · Received September 1, 2004

    Report

    Report Number
    2520313-2004-00015
    Event Type
    Death
    Date Received
    September 1, 2004
    Report Date
    September 1, 2004
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED TO ONE OF CO SALES REP THAT A PT DIED DURING A CONTRAST ENHANCED CT PROCEDURE. HOSP WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAILS ON THE EVENT OR MEDICAL HISTORY OF PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death