BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2110581 · Received May 24, 2011

    Report

    Report Number
    3003637274-2011-00032
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 11, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD TREATMENT AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND CAUSED A SMALL BURN TO LIP. THE DENTIST SUGGESTED SOME OVER THE COUNTER OINTMENT, BUT NOTHING WAS PRESCRIBED. NO FURTHER MEDICAL CARE WAS NECESSARY. THE ANALYSIS DID SHOW THAT THE HANDPIECE HAD A MEDIUM DEBRIS LEVEL, THE BEARINGS HAVE BEEN GRINDING AND ON THE SIDE OF IT HAS BEEN FALLING APART AND WOBBLING. THIS CAUSED THE HEAT TO HEAT UP. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE. EXEMPTION NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND CAUSED A SMALL BURN TO LIP. THE DENTIST SUGGESTED SOME OVER THE COUNTER OINTMENT, BUT NOTHING WAS PRESCRIBED. 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