BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX DENTALX-RAY MACHINE

    MDR report key: 21878 · Received May 18, 1995

    Report

    Report Number
    MW1005979
    Event Type
    Malfunction
    Date Received
    May 18, 1995
    Report Date
    May 9, 1995
    Manufacturer
    GENDEX CORP.
    Product Code
    EHD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DESIGN PROBLEM. TO GET X-RAY, A SETTING ON MACHINE DETERMINES AMOUNT OF EXPOSURE. THE DIAL HAS NO RELATIONSHIP TO ACTUAL AMOUNT OF X-RAY EXPOSURE. DIAL IS IMPROPERLY LABELED. CHANGING READOUT WOULD RECTIFY SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDEX DENTALX-RAY MACHINE DENTAL X-RAY MACHINE EHD GENDEX CORP. 404600G3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *