BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 20470114 · Received October 17, 2024

    Report

    Report Number
    3011300255-2024-00006
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    August 20, 2024
    Report Date
    October 17, 2024
    Manufacturer
    W&H DENTALWERK BUERMOOS GMBH
    Product Code
    EFB
    UDI-DI
    00304040153857
    PMA / PMN Number
    K162926
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE INCIDENT IS WEAR. THE HOLDING FORCE IS WORN OUT AFTER MORE THAN 24 MONTHS OF USE. IT CAN ALSO HAPPEN THAT THE PARTS WEAR OUT MORE QUICKLY WITH HEAVY USE AND LOW OIL MAINTENANCE. ACCORDING TO THE INSTRUCTIONS FOR USE, THE USER MUST CHECK THAT THE INSTRUMENTS ARE HELD SECURELY AND CARRY OUT A TEST RUN.

    Description of Event or Problem · 0

    DOCTOR WAS USING THE HANDPIECE ON THE PATIENT WHEN THE BUR DISLODGED FROM THE CHUCK AND WAS SWALLOWED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050432 HENRY SCHEIN DENTAL HANDPIECE EFB W&H DENTALWERK BUERMOOS GMBH MAXIMA ELITE 2 CA 00304040153857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other