BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE MRI

    MDR report key: 17912408 · Received October 10, 2023

    Report

    Report Number
    MW5146795
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 5, 2023
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT DEVELOPED A THERMAL BURN ON HIS RT ELBOW DURING MRI OF PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114999 GE MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC. 2415376

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male