BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT

    MDR report key: 7278672 · Received February 16, 2018

    Report

    Report Number
    2424472-2018-00009
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Report Date
    April 23, 2018
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR 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.

    Additional Manufacturer Narrative · 1

    INSERT WAS FOUND TO BE CLOGGED BY DRIED MEDICAMENT IN THE EDM HOLE.

    Description of Event or Problem · 1

    WHILE USING A 30K SFI-SLI-10S INSERT, THE INSERT HAS NO WATER COMING OUT AND IT BECOMES VERY HOT; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122492 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT SCALER, ULTRASONIC ELC DENTSPLY PROFESSIONAL NA 17236

    Patients

    Seq Age Sex Outcome Treatment
    1