BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 3937537 · Received June 26, 2014

    Report

    Report Number
    2411236-2014-00002
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DENTSPLY MAILLEFER INSTRUMENTS HOLDING SRL
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS WHILE PERFORMING A FILLING WITH THE CARBIDE BURS IT DETACHED ITSELF FROM THE HAND PIECE AND THE PT SWALLOWED IT. THE DENTIST WAS UNABLE TO RETRIEVE THE BUR; THEREFORE THE PT WAS REFERRED TO GET AN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373153 HENRY SCHEIN CARBIDE BURS FG CLINIC EJL DENTSPLY MAILLEFER INSTRUMENTS HOLDING SRL 1046559

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other