BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BRASSELER BRIO 450L

    MDR report key: 19030094 · Received April 3, 2024

    Report

    Report Number
    3010364969-2024-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Report Date
    April 3, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00887919872283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT SWALLOWED THE BUR.

    Description of Event or Problem · 0

    SURGICAL BUR CAME OUT OF HANDPIECE WHERE PATIENT SWALLOWED THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623179 BRASSELER BRIO 450L HANDPIECE EFB TTBIO CORP. BRIO 450L 00887919872283

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other