BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T POWER

    MDR report key: 1216263 · Received October 23, 2008

    Report

    Report Number
    1217116-2008-00076
    Event Type
    Other
    Date Received
    October 23, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 15, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR TO SUBMIT THIS EVENT THAT OCCURRED. PROBLEM: THE PT WAS HAVING AN MRI PROCEDURE. THE PT WAS SCANNED WITH THE SYNERGY BODY COIL (SBC) WITH THE FEET FIRST INTO THE MAGNET. THE SBC WAS PLACED OVER THE ANTERIOR AND POSTERIOR UPPER HIP/THIGH. THE PT COMPLAINED OF A WARMING BETWEEN HIS THIGHS AT THE END OF THE EXAM. ABOUT TWO HOURS AFTER THE EXAMINATION, A SECOND DEGREE BURN WITH A 2 CM BLISTER APPEARED ON ONE LEG. THERE WAS SKIN TO SKIN CONTACT BETWEEN THE TWO LEGS AT THE LOCATION OF THIS BURN. THE PT WAS TREATED WITH BURN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T POWER LNG (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNG PHILIPS MEDICAL SYSTEMS 781105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other