BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 18839754 · Received March 5, 2024

    Report

    Report Number
    2411236-2024-00002
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 5, 2024
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    UDI-DI
    10304040071509
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE A 35 YEAR OLD MALE PATIENT WAS HAVING A DENTAL SURGICAL EXTRACTION PROCEDURE THE PATIENT HEARD THE NOISE OF THE DRILL AND FELT THE VIBRATION AND CLAMPED DOWN ON THE HANDPIECE CLOSING HIS MOUTH. THIS MOTION DISLODGED THE BUR OUT OF THE HANDPIECE. THE PATIENT BEGAN TO COUGH MAKING IT DIFFICULT TO CAPTURE THE BUR WITH BOTH HIGH SPEED SUCTIONS IN THE MOUTH OF THE PATIENT. THE PATIENT WAS INSTRUCTED TO SIT UP AND COUGH HOWEVER THE BUR WAS NOT RECOVERED. THE PATIENT WAS IN GOOD CONDITION. THE PATIENT WAS GIVEN A REFERRAL FOR A CHEST RADIOGRAPH AND INSTRUCTED TO GO AS SOON AS POSSIBLE FOR LOCATING THE BUR. AS OF THE DATE OF THIS REPORT, THE REPORTER STATED THE PATIENT HAS NOT GONE TO GET AN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137168 HENRY SCHEIN CARBIDE BUR SURGICAL BONE FG 541A EJL PRIMA DENTAL GROUP 10304040071509

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other