BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T

    MDR report key: 1351624 · Received March 16, 2009

    Report

    Report Number
    1217116-2009-00019
    Event Type
    Other
    Date Received
    March 16, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 6, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MFR IN ANOTHER COUNTRY TO SUBMIT THIS INCIDENT THAT OCCURRED IN ANOTHER COUNTRY. THE PT HAD A MR PROCEDURE. THE PT WAS SCANNED WITH THE TORSO XL COIL FOR A HIP EXAMINATION WITH THEIR HEAD FIRST INTO THE MAGNET. PRIOR TO THIS EXAMINATION, THE PT HAD A LUMBAR SPINE EXAMINATION DURING WHICH SHE HEAVLY SWEATED. AFTER THE SCAN A FIRST DEGREE BURN APPEARED ON THE INSIDE OF THE LEFT KNEE THAT LATER BECAME A SECOND DEGREE BURN WITH A 3 CM BLISTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other