BEUDAMED
    FDA Adverse Event Summary report: N

    GATES GLIDDEN DRILL #4

    MDR report key: 542786 · Received September 8, 2004

    Report

    Report Number
    2411236-2004-12406
    Date Received
    September 8, 2004
    Date of Event
    September 5, 2004
    Report Date
    September 8, 2004
    Manufacturer
    LES FILS D'AUGUSTE MAILLEFER S.A.
    Product Code
    EKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT VISITED DENTIST IN EMERGENCY CLINIC ON SUNDAY FOR TREATMENT OF THE UPPER LEFT 2. GATES GLIDDEN DRILL #4 SHEARED OFF INTO THE CAVITY. DENTIST UNABLE TO REMOVE. PT WENT TO THEIR OWN DENTIST, WHO WAS UNABLE TO REMOVE THE DRILL FROM THE PULP; FILLED AROUND IT. TO CO'S KNOWLEDGE, PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATES GLIDDEN DRILL #4 ENDODONTIC DEVICE EKP LES FILS D'AUGUSTE MAILLEFER S.A. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other