BEUDAMED
    FDA Adverse Event Summary report: N

    HENRY SCHEIN

    MDR report key: 3161712 · Received June 6, 2013

    Report

    Report Number
    2411236-2013-00002
    Date Received
    June 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 20, 2013
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A (B)(6) FEMALE PATIENT SWALLOWED A BUR THAT DISLODGED FROM THE HANDPIECE WHILE HAVING A POLISHING. THE PATIENT WAS SAT UP IMMEDIATELY TO TRY AND COUGH IT OUT AND NOTHING CAME OUT. THE PATIENT WAS TAKEN TO URGENT CARE THEN THE ER. ON (B)(6) 2013 THE PATIENT WENT FOR AN ENDOSCOPY TO HAVE THE BUR SURGICALLY REMOVED. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250470 HENRY SCHEIN T AND F CARBIDE BURS FG EJL PRIMA DENTAL GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention