BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDWEST OPERATIVE CARBIDE BUR

    MDR report key: 6064300 · Received October 28, 2016

    Report

    Report Number
    1419322-2016-00271
    Event Type
    Injury
    Date Received
    October 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE INTERVENTION WAS REQUIRED IN THIS CASE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONLY UNUSED PRODUCT WAS RETURNED FOR EVALUATION. THE UNUSED DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT WHILE USING A HANDPIECE A 169-L TAPER FISSURE FG BUR FELL OUT AND WAS SWALLOWED BY A PEDIATRIC PATIENT. THE BUR WAS RETRIEVED BY MEANS OF AN ENDOSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714143 MIDWEST OPERATIVE CARBIDE BUR BUR, DENTAL EJL DENTSPLY PROFESSIONAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention