BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKELL

    MDR report key: 24794385 · Received April 6, 2026

    Report

    Report Number
    2411797-2026-00002
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 6, 2026
    Manufacturer
    PARKELL, INC
    Product Code
    ELC
    UDI-DI
    00810000522927
    PMA / PMN Number
    K950256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    PARKELL, INC. BECAME AWARE OF AN INCIDENT INVOLVING A PARKELL INSERT, THE DURA30-US, ON (B)(6) 2026. THE INSERT WAS IN USE BY A STUDENT WHEN IT BROKE OFF IN A PATIENT'S MOUTH. IT WAS CAUGHT IN THE TRAP AND IMMEDIATELY SUCTIONED OUT. NO INJURY WAS INITIALLY REPORTED. NO TREATMENT WAS SOUGHT. IMAGES OF THE INSERT WERE PROVIDED FOR EVALUATION. THE INSERT WAS RETURNED WITHOUT THE TIP. THE INSERT IS PART OF THE STUDENT INSTRUMENT PACKAGE. AS PART OF THE RESOLUTION, THE HYGIENE COORDINATOR AT THE UNIVERSITY WAS INSTRUCTED TO REMIND CLINICAL STUDENTS TO ADHERE TO THE PERFORMANCE GUIDE TO ENSURE PROPER DEVICE HANDLING AND USAGE PARAMETERS, MINIMIZING THE RISK OF MECHANICAL FATIGUE OR BREAKAGE. WE ARE FILLING THIS REPORT IN AN ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856107 PARKELL SCALER, ULTRASONIC ELC PARKELL, INC DURA30-US 00810000522927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown