BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL ELECTRIC MRI UNIT

    MDR report key: 15564 · Received July 20, 1994

    Report

    Report Number
    15564
    Event Type
    Other
    Date Received
    July 20, 1994
    Date of Event
    April 18, 1994
    Report Date
    May 18, 1994
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A BURNING SENSATION OF RIGHT POSTERIOR ARM ABOVE ALBOW DURING M. R.I SCAN. LATER NOTED A "TENDER LUMP" AND REPORTED 4/22/94MEDICAL EVALUATION 4/23/94 DESCRIBES A 8 X 10 CM TENDER LUMPS. NO EXUDATE OR SKIN DISCOLORATION.XRAY ARM REVEALED NO FOREIGN BODY. 12 AGNOSED AT SOFT TISSUE INJURY, POSTERIOR RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC MRI UNIT MRI SCANNER G.E. MEDICAL SYSTEMS SIGNA 1.5 TESLA MRI UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other