BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRA LUX MULTIFLEX TURBINE 635B

    MDR report key: 988415 · Received January 29, 2008

    Report

    Report Number
    8010493-2008-00002
    Event Type
    Injury
    Date Received
    January 29, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 4, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    KOJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS TAKEN TO ER FOR TREATMENT WHERE THEY WERE ABLE TO REMOVE THE PARTS. PATIENT WAS REPORTED TO BE IN GOOD CONDITION. PATIENT DID NOT REQUIRE ANY MEDICATION, BUT REQUESTED AN OVERNIGHT STAY AT HOSPITAL. IN 2008, DOCTOR REPORTED THAT PATIENT WAS FINE AND HE WILL SEE HER IN TWO WEEKS TO COMPLETE DENTAL WORK. PATIENT REFUSED TO RETURN THE COMPONENTS (TURBINE AND BUR) THAT ALLEGEDLY LODGED IN HER THROAT, THEREFORE, A FULL EVALUATION COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    DOCTOR WAS USING A 635B HANDPIECE AND IT CAME APART IN THE PATIENT'S MOUTH. THE TURBINE AND BUR BECAME LODGED IN PATIENT'S THROAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention