BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 18949888 · Received March 21, 2024

    Report

    Report Number
    3007007357-2024-00009
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 19, 2024
    Manufacturer
    HANDPIECE HEADQUARTERS
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    BUR DISLODGED FROM HANDPIECE DURING A SURGICAL EXTRACTION PROCEDURE WHERE PATIENT SWALLOWED THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532757 HENRY SCHEIN HANDPIECE EFB HANDPIECE HEADQUARTERS MAXIMA PRO 45

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other