BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BRASSELER

    MDR report key: 22492189 · Received July 14, 2025

    Report

    Report Number
    3010364969-2025-00009
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    February 25, 2025
    Report Date
    July 14, 2025
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00887919774594
    PMA / PMN Number
    K141183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, BACK CAP CAME OFF AND TURBINE DISLODGED FROM THE HANDPIECE, BRIO 440 (B)(4), DURING PROCEDURE, PATIENT SUFFERED FROM LOWER RIGHT CHEEK ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728575 BRASSELER HANDPIECE EFB TTBIO CORP. BRIO 440 00887919774594

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other