BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GXDP-300

    MDR report key: 6607953 · Received June 2, 2017

    Report

    Report Number
    2530069-2017-00009
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    PALODEX GROUP OY
    Product Code
    MUH
    UDI-DI
    06430035872435
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOLUME OF EXPOSURE WARNING SPEAKER OF A DIGITAL PANORAMIC X-RAY UNIT GXDP-300 (SERIAL # (B)(4)) IS TOO LOUD, AND HAS ALLEGEDLY CONTRIBUTED TO AN OPERATOR'S CLAIM OF PERMANENT RINGING IN EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390370 GXDP-300 DIGITAL PANORAMIC X-RAY UNIT MUH PALODEX GROUP OY GXDP-300 06430035872435

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability