BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRA LUX MULTIFLEX TURBINE 635B

    MDR report key: 1033371 · Received April 24, 2008

    Report

    Report Number
    8010493-2008-00007
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 27, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS SENT TO EMERGENCY AND BUR WAS REMOVED WITH NO PROBLEMS. NO MEDICATION WAS GIVEN AND PT WAS RELEASED THE SAME DAY. EVAL OF DEVICE FOUND THAT THE BEARINGS WERE WORN AND GRITTY, THERE WAS DAMAGE TO THE BACK END CAP, AND MEDIUM DEBRIS WAS PRESENT. MAINTENANCE ISSUES WERE DISCUSSED. HANDPIECE WAS REPLACED.

    Description of Event or Problem · 1

    BUR CAME OUT OF HANDPIECE AND LODGED IN PT'S THROAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRA LUX MULTIFLEX TURBINE 635B DENTAL HANDPIECE AND ACCESSORIES EKX KALTENBACH & VOIGT GMBH 635B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R