BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 20287346 · Received September 23, 2024

    Report

    Report Number
    3007007357-2024-00025
    Event Type
    Injury
    Date Received
    September 23, 2024
    Report Date
    September 24, 2024
    Manufacturer
    TTBIO CORP.
    Product Code
    EFB
    UDI-DI
    00304040090046
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER ADVISED THAT THE HEAD CAP CAME UNSCREWED AND POPPED OUT INTO PATIENTS MOUTH. NO INJURY TO PATIENT OR SWALLOWED PARTS, ALL PARTS WERE RETRIEVED FROM THE PATIENTS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290897 HENRY SCHEIN HANDPIECE EFB TTBIO CORP. MAXIMA PRO 2 HP STD HEAD 00304040090046

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other