BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E3 FOOT PEDAL

    MDR report key: 3810440 · Received April 14, 2014

    Report

    Report Number
    9611053-2014-00002
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    K103653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THIS ISSUE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE ISSUE WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 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 AN E3 FOOT PEDAL MALFUNCTIONED AND CAUSED A MOTOR TO RUN AND WOULD NOT STOP; THERE IS NO INDICATION THAT INJURY RESULTED. THE FOOT PEDAL WAS CHANGED AND THE DEVICE WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228086 E3 FOOT PEDAL CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1