BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA500 AUDIOMETER

    MDR report key: 2121306 · Received June 2, 2011

    Report

    Report Number
    2113281-2011-00001
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    January 12, 2010
    Report Date
    June 1, 2011
    Manufacturer
    DIAGNOSTIC GROUP LLC DBA TREMETRICS
    Product Code
    EWO
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDER GOING A HEARING TEST BY EMPLOYER. AT THE TIME OF THE TEST ELECTRICAL MAINTENANCE OR REPAIR WAS TAKING PLACE NEAR BY. AN ELECTRICAL POWER SYSTEM ANOMALY OCCURRED IN THE BUILDING WHERE THE TEST WAS BEING PERFORMED CAUSING A HIGH INTENSITY SPIKE IN POWER. THE PT CLAIMS TO HAVE EXPERIENCED AN EXPLOSIVE SOUND THROUGH THE AUDIOMETER AND INTO THE LEFT EAR. THE PT CLAIMS TO HAVE SUFFERED PERMANENT HEARING DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA500 AUDIOMETER AUDIOMETER EWO DIAGNOSTIC GROUP LLC DBA TREMETRICS RA500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability