BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS 1.5T INTERA

    MDR report key: 1851596 · Received September 23, 2010

    Report

    Report Number
    1851596
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT COMPLAINED OF OPEN SORES ON INNER THIGHS STATUS POST AN ABDOMINAL PELVIS MRI. PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND TREATMENT 5 DAYS AFTER THE MRI. PATIENT WAS NOTED TO HAVE A SECOND DEGREE BURN ON INNER THIGHS BY THE PHYSICIAN. THE NURSE'S DOCUMENTATION DESCRIBED AN OPEN BLISTER WOUND WITH ESCHAR, FIBROUS TISSUE AND NON-GRANULATING PINK TISSUE MEASURING 2.9 X 1.5 X 0.1 CM.WITHIN THE SAME WEEK, A FEMALE PATIENT COMPLAINED OF FEELING A BURNING PAINFUL SENSATION DURING THE MRI SCAN OF HER LEFT HIP/THIGH. THREE SEQUENCES WHERE COMPLETED WHEN THE PATIENT COMPLAINED AND THE SCAN WAS DISCONTINUED. THE PATIENT WAS EVALUATED BY THE RADIOLOGIST AND NO INJURY TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS 1.5T INTERA MRI LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA INC. INTERA MASTERS *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R NO OTHER THERAPIES
    2 25 YR