BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10L LEFT

    MDR report key: 10608111 · Received September 30, 2020

    Report

    Report Number
    2424472-2020-00039
    Event Type
    Injury
    Date Received
    September 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    PER CONDITION #1 OF FDA EXEMPTION #E2004001, EVENTS RESULTING IN SERIOUS INJURY ARE REPORTABLE PER 21CFR PART 803. VISUALLY INSPECTED AND CONFIRMED INSERT HAS A TIP FRACTURE AFTER THE EDM HOLE TOWARDS THE TIP DOES NOT MEET SPEC. INSERT IS BEYOND USEFUL LIFE. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 0

    WHILE USING A 30K SFI-SLI-10L INSERT, THE INSERT BROKE AND THE PATIENT INGESTED THE BROKEN PIECE. THE PATIENT HAD INITIALLY GONE TO THE EMERGENCY ROOM TO DETERMINE IF HE HAD SWALLOWED OR ASPIRATED THE BROKEN TIP. THEY DETERMINED HE HAD SWALLOWED IT. THEY HAD HIM COME BACK THE NEXT DAY AND PERFORMED AN ENDOSCOPY, BUT COULD NOT REACH THE BROKEN TIP. HE CAME BACK AGAIN FOR AN X-RAY FOR THEM TO FOLLOW ITS PROGRESS AND DETERMINE THAT NO DAMAGE HAD BEEN DONE. THE PATIENT THEN PASSED THE BROKEN PORTION OF THE TIP WITHOUT ANY FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075120 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10L LEFT SCALER, ULTRASONIC ELC DENTSPLY LLC NA 4337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention