BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX

    MDR report key: 3971026 · Received July 8, 2014

    Report

    Report Number
    2183553-2014-00016
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K121676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A BURN ON THE LEFT ELBOW DURING AN MRI EXAM OF THE LUMBAR SPINE THAT WAS DESCRIBED AS A BLISTER WITH PINK AROUND THE EDGES. THE BURN WAS APPROXIMATELY 1.5 INCHES IN DIAMETER. THE HOSPITAL REPORTED THAT THERE WAS ADEQUATE PADDING PLACED BETWEEN THE PATIENT'S ELBOW AND THE BORE OF THE MAGNET. THE PATIENT WAS KEPT IN THE HOSPITAL FOR AN OVERNIGHT STAY. HE WAS TREATED WITH ANTIBIOTICS AND CONSULTED TO PLASTIC SURGERY FOLLOWING THE ONSET OF A SECONDARY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397921 1.5T SIGNA HDX NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other