BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDWEST

    MDR report key: 16588530 · Received March 21, 2023

    Report

    Report Number
    3007007357-2023-00001
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 21, 2023
    Manufacturer
    HANDPIECE HEADQUARTERS
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A DIAMOND BUR SHOT OUT OF THE HANDPIECE WHILE IN USE, RESULTED TO PATIENT SWALLOWING BUR AND BEING SENT TO THE HOSPITAL FOR A PROCEDURE TO REMOVE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938084 MIDWEST TURBINE EFB HANDPIECE HEADQUARTERS MIDWEST STYLUS MINI 540S/ 541S PB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention