BEUDAMED
    FDA Adverse Event Injury Summary report: N

    445GE - 64 WRIST COIL

    MDR report key: 408499 · Received July 30, 2002

    Report

    Report Number
    2183683-2002-00001
    Event Type
    Injury
    Date Received
    July 30, 2002
    Report Date
    July 25, 2002
    Manufacturer
    IGC MEDICAL ADVANCES, INC.
    Product Code
    MOS
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTAL SIDE OF THE PATIENT'S ELBOW WAS BURNED DURING AN MRI SCAN OF THE PATIENT WRIST. DEVICE IS LOCATED AT THE PATIENT'S WRIST DURING THE SCAN. PER THE USER FACILITY, NO PART OF THE DEVICE (COIL OR CABLE) WAS IN CONTACT WITH THE LOCATION. THE PATIENT WAS BURNED AT (ELBOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 445GE - 64 WRIST COIL MRI WRIST IMAGING COIL MOS IGC MEDICAL ADVANCES, INC. 445 GE-64 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other