BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREMETRICS RA300

    MDR report key: 4908282 · Received July 9, 2015

    Report

    Report Number
    2113281-2015-00001
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 8, 2015
    Manufacturer
    TREMETRICS
    Product Code
    EWO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND DEVICE HISTORY RECORDS WERE REVIEWED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURE, AND THE DEVICE MET SPECIFICATION AT THE TIME OF RELEASE. IN ADDITION, FURTHER TESTING WAS CONDUCTED ON THE RETURNED DEVICE AND ALL SPECIFICATIONS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TREMETRICS RA300 AUDIOMETER CAUSED HEARING LOSS 1 WEEK AFTER A NORMAL HEARING TEST. THE PT DID NOT COMPLAIN OF PAIN OR HEARING LOSS DURING OR AFTER THE EXAM. THE PT DID COMPLAIN OF A LOUD TONE, HOWEVER, THE CLINICIAN RE-EXPLAINED THE TEST PROCEDURE AND THE TEST WAS COMPLETED WITHOUT ANY FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444711 TREMETRICS RA300 AUDIOMETER EWO TREMETRICS RA300+

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other