BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD STELLANT INJECTION SYSTEM

    MDR report key: 20999978 · Received December 20, 2024

    Report

    Report Number
    MW5163837
    Event Type
    Injury
    Date Received
    December 20, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALLER STATES THEY USE SOME OFF LABEL REFILL KITS (SALIENT) AND OTHERS AND THE NURSES /HCPS ARE CLAIMING THEY ARE LEAKING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79573 MEDRAD STELLANT INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BAYER MEDICAL CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown