BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE

    MDR report key: 2175154 · Received July 19, 2011

    Report

    Report Number
    MW5021430
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL RECEIVED AN MRI ON A MOBILE 1.5T GE LX HIGHSPEED MRI. THE INDIVIDUAL REPORTED FEELING A TEMPERATURE INCREASE OF HIS SKIN ON HIS ARMS. SINCE THE PROCEDURE, THE INDIVIDUAL REPORTS FEELING AS IF HE HAS A "SUNBURN" UNDER HIS SKIN, BURNING AND DRYNESS OF THE EYES AND IF HE HAS A MILD WELDING BURN. MRI OF THE PELVIS. DATES OF USE: 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE MRI 1.5 LX HIGHSPEED - MOBILE LNH GE SIGNA HIGHSPEED L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other