BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-PWR-FG-100 INSERT,PKD

    MDR report key: 16689786 · Received April 6, 2023

    Report

    Report Number
    2424472-2023-00367
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Report Date
    April 6, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION 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 · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-FG-100 INSERT,PKD ALLEGEDLY NO WATER FLOW AND HAND PIECE GETS HOT DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798389 30K FSI-PWR-FG-100 INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 22223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown