BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUNGSTEN CARBIDE METAL TRIMMING BUR

    MDR report key: 2202375 · Received August 3, 2011

    Report

    Report Number
    8031010-2011-00117
    Event Type
    Injury
    Date Received
    August 3, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EJL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER CONDITION #1 OF EXEMPTION (B)(4), EVENTS MEETING THE DEFINITION OF A SERIOUS INJURY ARE REQUIRED TO BE REPORTED. THEREFORE, MEDICAL INTERVENTION WAS NECESSARY TO PRECLUDE PERMANENT DAMAGE IN THIS EVENT, IT DOES MEET THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. EVALUATION OF THE RETURNED DEVICE REVEALED IT WAS WITHIN SPECIFICATION. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A CARBIDE BUR SEPARATED DURING TREATMENT; THE SEPARATED PIECE WAS RETRIEVED. THE PATIENT WAS CUT ON THEIR UPPER LIP. THE DOCTOR TREATED THE CUT WITH A PRESCRIPTION VOLON A SALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNGSTEN CARBIDE METAL TRIMMING BUR EJL DENTSPLY MAILLEFER 8793870

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention