BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMATIC LUX CONTRA ANGEL 25 LHA

    MDR report key: 3745920 · Received January 14, 2014

    Report

    Report Number
    3003637274-2014-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 23, 2013
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE BEARINGS HAVE BEEN GRINDING. ALSO THE WATER SPRAY HAS BEEN CLOGGED AND THE BUR GUIDE HAS BEEN BROKE. THE HANDPIECE HAS NOT BEEN SERVICED SINCE 2007. THE HEAT UP WAS REPRODUCIBLE DURING A SHORT TEST RUN. ALL FINDINGS BESIDE THE CLOGGED WATER SPRAY ARE THE RESULT OF THE NORMAL WEAR PROCESS. THE WORN BEARINGS CAUSE A HIGHER FRICTION AND HENCE A INCREASE OF TEMPERATURE, THE CLOGGED WATER SPRAY CAUSES ALSO A REDUCED COOLING OF THE HANDPIECE. THE USER INSTRUCTION STATES THAT ONLY FAULT FREE PRODUCTS SHOULD BE USED. A VISUAL AND FUNCTIONAL INSPECTION TEST PRIOR TO EACH TREATMENT IS MANDATORY. REPORTED DUDE TO THE 2 YEAR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE GOT HOT AND BURNED THE PT ON LIP. THE BURN WAS SLIGHTLY LARGER THAN A PEA PER DENTAL OFFICE. THE BURN WAS TREATED WITH SOME OTC OINTMENTS. NO MEDICAL CARE WAS NECESSARY. DENTAL OFFICE DOES NOT RECALL THE PATIENTS NAME, HENCE IT IS NOT POSSIBLE TO SUPPLY PATIENTS AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34862 INTRAMATIC LUX CONTRA ANGEL 25 LHA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25 LHA

    Patients

    Seq Age Sex Outcome Treatment
    1