BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 13005638 · Received December 14, 2021

    Report

    Report Number
    2411236-2021-00004
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    September 8, 2021
    Report Date
    November 17, 2021
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE DENTIST WAS PERFORMING A PROCEDURE ON A MALE PATIENT WHEN THE MULTI-FLUTED BUR CAME OUT OF THE HIGHSPEED HANDPIECE AND THE PATIENT HAD SWALLOWED IT. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895867 HENRY SCHEIN CARBIDE BUR T&F 12 BLADE FG EJL PRIMA DENTAL GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention