BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURS CARBIDE FG 557

    MDR report key: 1246053 · Received November 25, 2008

    Report

    Report Number
    2411236-2008-25723
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    LES FILS D'AUGUSTE MAILLEFER S.A.
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTIST CLAIMS THAT THE BURS BREAK AS SOON AS THEY TOUCH THE TOOTH. THE HAVE HAD ABOUT 60 BURS BROKEN. NO PT WAS INJURED AND ALL THE PIECES WERE EITHER SPIT OUT BY THE PT OR RETRIEVED WITH FORCEPS.

    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. 429554C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other