BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5T INTERA

    MDR report key: 1278603 · Received December 29, 2008

    Report

    Report Number
    1217116-2008-00092
    Event Type
    Other
    Date Received
    December 29, 2008
    Date of Event
    December 1, 2008
    Report Date
    December 1, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN MR PROCEDURE PERFORMED ON HER. THE PT WAS SCANNED WITH THE 8 CHANNEL SENSE HEAD COIL WITH THE HEAD FIRST INTO THE MAGNET. THE PT WAS LARGE, AND THEREFORE HER SHOULDERS WERE AGAINST THE SIDES OF THE BORE. AFTER A FEW SCANS, THE PT COMPLAINED OF A HEATING SENSATION ON THE LEFT ARM. THE OPERATOR THEN PLACED A BLANKET BEHIND THE PT'S LEFT ARM TO ISOLATE IT FROM THE COIL AND RESUMED THE SCANNING. AFTER COMPLETING THE EXAMINATION, A SECOND DEGREE BURN WITH A .635 X 3.175 INCH BLISTER WAS NOTICED ON THE POSTERIOR LEFT UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T INTERA LNH (MAGNETIC RSONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 781195 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other