BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1069863 · Received June 9, 2008

    Report

    Report Number
    1069863
    Date Received
    June 9, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 9, 2008
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Product Code
    MOS
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCREENED FOR METAL BEFORE PROCEDURE. NO METAL FOUND AND PATIENT CLEARED FOR MRI. SHOULDER COIL PLACED ON PATIENT AND PUT INTO MAGNET. DURING SCAN PATIENT FELT A SHOCK IN HIS ABDOMEN AND BURNING ON SHOULDER. NO METAL FOUND ANYWHERE ON PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MRI COIL MOS IGC-MEDICAL ADVANCES, INC. 415GE - 64A *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR NO OTHER THERAPIES| NO OTHER THERAPIES