BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 148021 · Received January 8, 1998

    Report

    Report Number
    148021
    Event Type
    Injury
    Date Received
    January 8, 1998
    Date of Event
    November 6, 1997
    Report Date
    December 16, 1997
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT MRI SCAN OF LUMBAR AND THORACIC SPINE TO RULE OUT TUMOR. NUMEROUS SERIES WERE TAKEN, EACH TAKING APPROX 3-5 MINUTES. PT DID NOT HAVE COMPLAINTS OF PAIN DURING EXAM. ON 11/19, PT SEEN BY PRIMARY CARE PHYSICIAN WITH BLISTERING TO LOWER SPINAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC MEDICAL SYSTEMS 1.5 CTL COIL LNH GENERAL ELECTRIC MEDICAL SYSTEMS 46-32097161 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention