BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS INTERA 1.5T

    MDR report key: 689744 · Received February 23, 2006

    Report

    Report Number
    MW1038120
    Event Type
    Injury
    Date Received
    February 23, 2006
    Date of Event
    February 17, 2006
    Report Date
    February 23, 2006
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED HEATING SENSATION REQUIRING THE INTERRUPTION OF THE MRI OF THE LUMBAR SPINE. HE COMPLAINED OF SMALL BLISTER ON BOTH ARMS FOLLOWING THE DISCONTIUATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS INTERA 1.5T MAGNETIC REASONANCE DIAGNOSTIC DEVICE LNH PHILIPS MEDICAL SYSTEMS N84152NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR