BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDRAD CT INJECTOR

    MDR report key: 123342 · Received September 29, 1997

    Report

    Report Number
    2520313-1997-00041
    Event Type
    Other
    Date Received
    September 29, 1997
    Date of Event
    August 25, 1997
    Report Date
    September 25, 1997
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL PERSONNEL REPORTED THAT AN EXTRAVASATION OCCURRED AND THAT A TECHNOLOGIST WAS UNABLE TO DISARM THE INJECTOR AT THE INJECTOR HEAD OR DCU. NO INJURY RESULTED.

    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 * Other