BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 23333980 · Received October 19, 2025

    Report

    Report Number
    3010364969-2025-00011
    Event Type
    Malfunction
    Date Received
    October 19, 2025
    Date of Event
    March 10, 2025
    Report Date
    October 20, 2025
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00887919821670
    PMA / PMN Number
    K141183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, THE BACK CAP AND TURBINE OF THE HANDPIECE, BRIO 440F (B)(4) WITH BUR BROKE APART IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819766 HENRY SCHEIN HANDPIECE EFB TTBIO CORP. BRASSELER 00887919821670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other