BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR

    MDR report key: 14111298 · Received April 13, 2022

    Report

    Report Number
    MW5108968
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    August 9, 2021
    Report Date
    April 11, 2022
    Manufacturer
    DENTALEZ, INC., STARDENTAL DIVISION
    Product Code
    DZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BUR DISENGAGED FROM HAND PIECE AND PT SWALLOWED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415875 BUR INSTRUMENT, DIAMOND, DENTAL DZP DENTALEZ, INC., STARDENTAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| O