BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, CONTRAST MEDIUM, AUTOMATIC

    MDR report key: 13839966 · Received March 21, 2022

    Report

    Report Number
    13839966
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    October 15, 2021
    Report Date
    March 1, 2022
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY LLC
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INJECTION OF 20 ML OF DOTAREM® IN RIGHT ARM USING A POWER INJECTOR (LOT NUMBER P259A). NO CONTRAST SHOWED UP ON IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547616 INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ LIEBEL-FLARSHEIM COMPANY LLC P259A

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Unknown