BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD STELLANT CT INJECTION SYSTEM

    MDR report key: 6848232 · Received September 7, 2017

    Report

    Report Number
    MW5071991
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    June 16, 2017
    Report Date
    September 5, 2017
    Manufacturer
    BAYER
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OPENED INJECTOR PACK AND WENT TO THREAD INJECTOR ON INJECTOR AND NOTICED THAT THE THREAD WAS BROKEN. NOT USED ON PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629463 MEDRAD STELLANT CT INJECTION SYSTEM STERILE DISPOSABLE SYRINGES FMF BAYER 8530965

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention