BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T PULSAR

    MDR report key: 1179663 · Received September 22, 2008

    Report

    Report Number
    1217116-2008-00069
    Event Type
    Other
    Date Received
    September 22, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD A MR EXAMINATION. THE PT WAS SCANNED WITH THE FLEX-M COIL WITH THE HEAD FIRST INTO THE MAGNET. THE COIL WAS POSITIONED AT BOTH SIDES OF THE HIP. PT WAS WEARING SCRUBS DURING THE EXAMINATION. ABOUT THREE HRS AFTER THE EXAMINATION, A SECOND DEGREE BURN 2.5 CM X 4 CM WAS NOTICED ON THE BACK SIDE OF THE RIGHT UPPER LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other