BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXCITE 3.0T

    MDR report key: 1242944 · Received November 21, 2008

    Report

    Report Number
    2183553-2008-00056
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A PATIENT REPORTEDLY SUSTAINED BUZZING AND TEMPORARY HEARING LOSS AFTER BEING SCANNED ON A GE MR SCANNER. THE PATIENT WAS WEARING EAR PLUGS WHILE BEING SCANNED. IT IS UNK AT THIS TIME AS TO WHETHER OR NOT THE PATIENT RECEIVED ANY MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA EXCITE 3.0T LNH GE MEDICAL SYSTEMS, LLC 2357500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other