BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 750W

    MDR report key: 8315352 · Received February 6, 2019

    Report

    Report Number
    MW5083801
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 5, 2019
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE MRI SCAN THE PATIENT COMPLAINED ABOUT LOUD NOISE FROM HIS RIGHT EAR. WE CHECKED ON HIM AND FOUND THE LARGER EAR PLUG WAS IN HIS EAR ALMOST ALL THE WAY. I WAS ABLE TO PUT IT IN FURTHER AND USED THE SMALL FOLD-BLE CUSHION TO KEEP IT IN PLACE AND SOMEWHAT COVER HIS EAR AT THE SAME TIME. WE FINISHED THE EXAM WITHOUT FURTHER COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103290 GE 750W SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC 750W
    103291 EAR PLUGS PROTECTOR, HEARING (INSERT) EWD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention