BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT

    MDR report key: 7452392 · Received April 23, 2018

    Report

    Report Number
    2424472-2018-00055
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Report Date
    May 29, 2018
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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

    EVALUATION FOUND THE INERT IS CLOGGED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE PATIENT OUTCOME.

    Description of Event or Problem · 1

    WHILE USING A 30K SFI-SLI-10S INSERT, THERE WAS NO WATER FLOW AND THE INSERT WAS GETTING HOT. THE EVENT OUTCOME IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292815 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT SCALER, ULTRASONIC ELC DENTSPLY PROFESSIONAL NA 17275

    Patients

    Seq Age Sex Outcome Treatment
    1