BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURS CARBIDE FG 557

    MDR report key: 1240525 · Received November 19, 2008

    Report

    Report Number
    2411236-2008-25116
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    LES FILS D'AUGUSTE MAILLEFER S.A.
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE BURS BROKE WHEN DENTIST TOUCHED THE TOOTH OF A PATIENT. THERE WERE NO PATIENT INJURIES AND ALL OF THE PIECES WERE RETRIEVED. THEY HAD OVER 10 BURS BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURS CARBIDE FG 557 BURS CARBIDE FG 557 EJL LES FILS D'AUGUSTE MAILLEFER S.A. 364789A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other