BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAPREP 2 OVEN

    MDR report key: 6408987 · Received March 16, 2017

    Report

    Report Number
    8031010-2017-00016
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    February 24, 2017
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. ON THE DEVICE THERE ARE NO MECHANIC OR ELECTRIC DEFECTS DETECTED. THE HEATING ELEMENTS WHICH ARE POLLUTED AND GLUED WITH GUTTAPERCHA, WERE CLEANED. NO FURTHER FAULTS WERE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A THERMAPREP 2 OVEN, A DENTAL ASSISTANT RECEIVED AN ELECTRIC SHOCK; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191072 THERMAPREP 2 OVEN GUTTA-PERCHA EKM DENTSPLY MAILLEFER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1