BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 3T MRI

    MDR report key: 1202340 · Received October 15, 2008

    Report

    Report Number
    MW5008647
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    May 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    GE MEDICAL SYSTEM
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MRI FOR BENIGN SUPRASELLAR BRAIN TUMOR FOLLOWUP. USED 3T MRI. INADEQUATE HEARING PROTECTION RESULTED IN CHRONIC TINNITUS AND DOCUMENTED HEARING LOSS. PT COMPLAINED PART WAY THRU EXAM AND WHEN EXAM STOPPED FOR CONTRAST INJECTION TECH PUSHED ON EARS TO "RE-SEAT" EARPLUGS AND PT SAID NOISE DECREASED SLIGHTLY. DIAGNOSIS OR REASON FOR USE: BENIGN BRAIN TUMOR. EVENT ABATED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE 3T MRI GE 3T MRI LNH GE MEDICAL SYSTEM 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention