BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE

    MDR report key: 17836613 · Received September 27, 2023

    Report

    Report Number
    MW5146266
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    September 21, 2023
    Report Date
    September 25, 2023
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER THE PATIENT WENT HOME, HE NOTICED A RED AREA WITH A LUMP NEAR HIS RIGHT ELBOW. HE CALLED AND SAID THAT HE THOUGHT HE MAY HAVE GOT BITTEN BY AN INSECT IN THE MRI SCANNER. WE ASKED IF HE WANTED TO GO TO THE EMERGENCY ROOM AND HE DECLINED AND IT WAS DECIDED THAT WE WOULD FOLLOW UP THE NEXT DAY. THE NEXT DAY, THE PATIENT SHOWED UP AT THE HOSPITAL SO THAT WE CAN VISUALIZE THE AREA OF CONCERN. THE RIGHT ELBOW WAS RED WITH A BLISTER IN THE MIDDLE. A RADIOLOGIST WAS ASKED TO EXAMINE THE AREA. IT WAS DECIDED THAT IT WAS AN RADIO FREQUENCY BURN. THE PATIENT DECLINED TREATMENT. THE PATIENT ADMITTED TO MOVING IN THE SCANNER AND HIS ARM MAY HAVE MOVED AWAY FROM THE CUSHIONS USED TO PROTECT THE SKIN. GENERAL ELECTRICIAN WAS CALLED AND THE SCANNER HAD A MAINTENANCE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003572 GE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC SIGNA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male