BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA LUX HEAD 68 LH

    MDR report key: 4118997 · Received September 19, 2014

    Report

    Report Number
    3003637274-2014-00031
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 26, 2014
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS SHOWED THAT THE PUSH BUTTON OF THE CHUCK RELEASE STUCK IN. THIS CAUSED UNUSUAL INNER FRICTION AND THEREFORE HEAT UP OF THE HEAD. ROOT CAUSE WAS A DENT IN THE HEAD WHICH INDICATES THAT IT RECEIVED A STRONG HIT, E.G. DROPPING DURING RE-PROCESSING.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HEAD HEATED UP AND CAUSED A BURN IN PATIENTS MOUTH. THE PATIENT WAS GIVEN AN OTC OINTMENT FOR THE BURN. IT HEALED ALREADY FULLY. FURTHER INFORMATION RELATED TO PATIENT HAVE NOT BEEN SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583763 INTRA LUX HEAD 68 LH DENTAL HANDPIECE EFB KAVO DENTAL GMBH 68 LH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR