BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA500 AUDIOMETER

    MDR report key: 1734655 · Received June 23, 2010

    Report

    Report Number
    2113281-2010-00001
    Event Type
    Injury
    Date Received
    June 23, 2010
    Date of Event
    August 5, 2009
    Report Date
    May 6, 2010
    Manufacturer
    DIAGNOSTIC GROUP, LLC
    Product Code
    EWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE SEARCHES REGARDING EXPOSURE TO LOUD SOUNDS, INCLUDING THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) AND NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH) GUIDELINES, SHOW THAT GIVEN A 120DB, 50MS NOISE THAT WOULD FALL WITHIN THE GUIDELINES FOR ALLOWABLE EXPOSURE. FURTHERMORE, A BRIEF EXPOSURE TO A NOISE OF 120DB SPL AT 1000 HZ WOULD HAVE NO PERMANENT EFFECT ON HEARING SENSITIVITY AND IS UNLIKELY TO CAUSE EVEN A TEMPORARY THRESHOLD SHIFT (TTS).

    Description of Event or Problem · 1

    A HEALTHY PATIENT, WITH NO PRIOR HEARING ISSUES, ENTERED A "HEARING CHAMBER", HAD HEADPHONES PLACED ON AND UNDERWENT A HEARING TEST. THE PATIENT CLAIMS TO HAVE EXPERIENCED A LOUD SOUND THROUGH HIS LEFT EAR. PATIENT CLAIMS TO HAVE SUFFERED A HEARING LOSS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability