BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUTTACORE OBTURATOR OVEN

    MDR report key: 4910086 · Received July 9, 2015

    Report

    Report Number
    2320721-2015-00007
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    June 11, 2015
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EKM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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, PARTICULARLY IF THIS ISSUE OCCURRED WITH A PERSON WHO IS IMPLANTED WITH A PACEMAKER. THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE 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 DOCTOR RECEIVED AN ELECTRICAL SHOCK WHEN HE PLUGGED A GUTTACORE OBTURATOR OVEN INTO THE ELECTRICAL SOCKET; NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444796 GUTTACORE OBTURATOR OVEN EKM DENTSPLY TULSA DENTAL SPECIALTIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1