BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, CONTRAST MEDIUM, AUTOMATIC

    MDR report key: 13839217 · Received March 21, 2022

    Report

    Report Number
    13839217
    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 14ML OF DOTAREM IN LEFT UPPER ARM, LOT NUMBER P259A (20ML BOTTLE) DID NOT SHOW UP ON IMAGES. IT DID NOT SEEM LIKE THE ARM WAS INFILTRATED. NO PAIN OF DISCOMFORT TO PATIENT. HEALTH CARE PROVIDER FELT THE ARM SOFT AND NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550836 INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ LIEBEL-FLARSHEIM COMPANY LLC P259A

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA Unknown