BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 6515728 · Received April 24, 2017

    Report

    Report Number
    2411236-2017-00001
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 11, 2017
    Report Date
    April 14, 2017
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REFERENCE REPORT NUMBER MW5068737. THE DENTIST WAS SECTIONING A TOOTH OF A PATIENT WHEN THE BUR BROKE IN HALF. THE DENTIST TOOK A PANORAMIC XRAY OF THE PATIENT'S MOUTH AT THE OFFICE AND SAW THAT A PIECE OF THE BUR THAT BROKE WAS STILL IN AN AREA OF THE PATIENT'S CHEEK. THE PATIENT WAS THEN ASKED TO RINSE THEIR MOUTH OUT. AFTER THE PATIENT RINSED THEIR MOUTH THE OFFICE TOOK A SECOND PANORAMIC XRAY AT THE OFFICE AND DID NOT SEE ANYTHING. AS A PRECAUTIONARY MEASURE THE OFFICE DECIDED TO SEND THE PATIENT TO AN OFFSITE FACILITY FOR A CHEST XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297039 HENRY SCHEIN CARBIDE SURGICAL BUR FG 557 EJL PRIMA DENTAL GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other