BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2591376 · Received May 24, 2012

    Report

    Report Number
    3003637274-2012-00029
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 27, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD TREATMENT, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED THE PTS CHEEK ON 2 LOCATIONS TO THE DIAMETER OF 2MM AND 3MM. THE PT RECEIVED SOME OTC ANBESOL OINTMENT FOR THE BURN. NO FURTHER MEDICAL CARE WAS NECESSARY. THE ANALYSIS DID SHOW THAT THE HEAD HAD BEEN DENTED AT THE BACKCAP. THIS CAUSED THE BACK CAP BUTTON TO STICK IN WHICH CAUSED INTERNAL FRICTION AND AS A RESULT THE STRONG INCREASE OF TEMP. EXPERIENCE SHOWS THAT THIS IS USUALLY THE RESULT OF A STRONG HIT LIKE E.G. A DROP DURING THE REPROCESSING. IN ADDITION THE BEARINGS HAVE BEEN GRITTY WHICH COULD BE NORMAL WEAR OR POSSIBLY STRONGER WEAR CAUSED BY THE HEAT. DURING THE TEST RUN THE HEAT UP WAS REPRODUCIBLE. THE USER INSTRUCTION REQUIRES A VISUAL AND FUNCTIONAL INSPECTION PRIOR TO EACH TREATMENT WHICH SHOWS IF DEVICE IS RUNNING OUT OF SPECIFICATION AND IS HENCE MANDATORY. REPORTED DUE TO THE 2 YR PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, A DENTAL ELECTRICAL HANDPIECE GOT HOT AND BURNED THE PTS CHEEK ON 2 LOCATIONS TO THE DIAMETER OF 2MM AND 3MM. THE PT RECEIVED SOME OTC ANBESOL OINTMENT FOR THE BURN. NO FURTHER MEDICAL CARE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR