BEUDAMED
    FDA Adverse Event Summary report: N

    SYNERGY BODY COIL

    MDR report key: 1728963 · Received June 2, 2010

    Report

    Report Number
    1728963
    Date Received
    June 2, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 2, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    MOS
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MRI ON KNEE. KNEE PLACED IN SYNERGY BODY COIL. SHEET USED TO COVER BODY COIL. PT EXPERIENCED A BURN TO POSTERIOR THIGH ABOUT THE SIZE OF A QUARTER. BLISTER NOTED. FELT THE COIL HEATED UP TOO MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY BODY COIL IMAGING COIL, MRI MOS PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 1.5T IPX4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NO OTHER THERAPIES