BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMAPREP2 OVEN

    MDR report key: 11891707 · Received May 26, 2021

    Report

    Report Number
    8031010-2021-00092
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    October 11, 2021
    Product Code
    EKM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    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. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASSISTANT GOT AN ELECTRIC SHOCK DURING USE OF A THERMAPREP 2 OVEN; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787515 THERMAPREP2 OVEN GUTTA-PERCHA EKM NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1