BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBIDE FLUTED

    MDR report key: 6208329 · Received December 28, 2016

    Report

    Report Number
    6208329
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 12, 2016
    Manufacturer
    BRASSELER U.S.A. DENTAL, LLC
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE, THE TAPER CARBIDE FLUTED STANDARD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858717 CARBIDE FLUTED BUR, DENTAL EJL BRASSELER U.S.A. DENTAL, LLC 14CO608 NM5XY

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR