BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATIP

    MDR report key: 23815789 · Received December 16, 2025

    Report

    Report Number
    2411797-2025-00003
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 10, 2025
    Manufacturer
    PARKELL, INC
    Product Code
    ELC
    UDI-DI
    00810000522927
    PMA / PMN Number
    K950256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE RECEIVED A COMPLAINT INVOLVING OUR DURA30-US INSERT. THIS INSERT IS AN ACCESSORY TO OUR "TURBO" ULTRASONIC SCALER. INITIAL COMPLAINT INDICATED THAT THE TIP BROKE. SUBSEQUENTLY WE DISCOVERED THAT, UPON INITIATION OF PROCEDURE, THE INSERT TIP BROKE IN THE PATIENT'S MOUTH. THERE WAS NO INJURY TO EITHER THE HYGIENIST OR THE PATIENT. THE TIP WAS IMMEDIATELY RECOVERED. THE INSERT WAS RETURNED FOR EVALUATION MINUS THE BROKEN TIP. THE INSERT IS UNDER EVALUATION. WE ARE FILING THIS REPORT WITH AN OVERABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444592 DURATIP SCALER, ULTRASONIC ELC PARKELL, INC DURA30-US 00810000522927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male