BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTAFUSION OBTURATOR OVEN

    MDR report key: 7940272 · Received October 5, 2018

    Report

    Report Number
    9611053-2018-00149
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Report Date
    December 4, 2018
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKM
    PMA / PMN Number
    NA
    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 IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A GUTTA FUSION OVEN, WHEN REMOVING IT FROM THE SOCKET ONLY, HAPPENED TO CAUSE AN ELECTRIC SHOCK; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778180 GUTTAFUSION OBTURATOR OVEN GUTTA-PERCHA EKM DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1