BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE SIGNA HDXT 1.5T

    MDR report key: 15958926 · Received December 9, 2022

    Report

    Report Number
    MW5113718
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 7, 2022
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS UPPER BODY BURNS ON HIS NECK, CHEST, BACK, AND FOREHEAD AFTER A CERVICAL SPINE MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425008 GE SIGNA HDXT 1.5T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other