BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HENRY SCHEIN

    MDR report key: 23333981 · Received October 19, 2025

    Report

    Report Number
    3010364969-2025-00010
    Event Type
    Malfunction
    Date Received
    October 19, 2025
    Date of Event
    May 8, 2025
    Report Date
    October 20, 2025
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00304040058336
    PMA / PMN Number
    K141183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, WHILE DOCTOR WAS WORKING ON CHILD PATIENT, BUR SLIPPED OUT OF CHUCK FROM THE HANDPIECE, MAXIMA ELITE MINI L (B)(4), AND CUT CHILD'S CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819767 HENRY SCHEIN HANDPIECE EFB TTBIO CORP. MAXIMA ELITE L MINI 00304040058336

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other