BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXCITE II HD

    MDR report key: 1022609 · Received April 1, 2008

    Report

    Report Number
    2183553-2008-00017
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE FACILITY'S LEAD TECHNICIAN, THE PT WAS PADDED. THE PT'S HAND WERE NOT CLASPED, AND SHE HAD NO METAL ON HER BODY. AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED 2ND-DEGREE BURNS ON HER KNUCKLE AND ELBOW AFTER AN MR SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA EXCITE II HD LNH GE MEDICAL SYSTEMS, LLC 2226300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other