BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC.

    MDR report key: 8304911 · Received February 5, 2019

    Report

    Report Number
    2411236-2019-00001
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 5, 2019
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHILE DELIVERING A CROWN ON A (B)(6) MALE PATIENT, THE ENTIRE BUR FELL OUT OF THE HANDPIECE INTO THE PATIENT'S MOUTH. THE PATIENT SWALLOWED THE BUR AND WAS SENT FOR AN X-RAY. THE DR. CONFIRMED THE PATIENT WAS FINE AND NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE DR. STATED THERE WERE NO CHANGES IN THE PATIENT'S CONDITION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98605 HENRY SCHEIN INC. CARBIDE BUR EJL PRIMA DENTAL GROUP 1165450

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other