BEUDAMED
    FDA Adverse Event Summary report: N

    HELIODENT MD

    MDR report key: 26570 · Received August 8, 1995

    Report

    Report Number
    1017522-1995-00001
    Date Received
    August 8, 1995
    Date of Event
    July 18, 1995
    Report Date
    August 8, 1995
    Manufacturer
    PELTON & CRANE CO.
    Product Code
    EHD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT MAY HAVE EMITTED UNANTICIPATED RADIATION. THE REPAIR TECH DID NOT ACTUALLY VERIFY THE EMISSION OF RADIATION, BUT ASSUMED THAT UNIT EXPOSED BASED ON MALFUNCTIONING MULTITIMER. REPORT HAS BEEN FORWARDED TO MFR FOR FAILURE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIODENT MD INTRAORAL DENTAL X-RAY UNIT EHD PELTON & CRANE CO. 20237 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *