BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 2182621 · Received July 4, 2011

    Report

    Report Number
    3003637274-2011-00041
    Event Type
    Malfunction
    Date Received
    July 4, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 6, 2011
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE BEARINGS HAVE BEEN GRITTY AND THE HEAD HAD DENTS WHICH CAUSED THE BACKCAP TO STICK IN. THIS CAUSED THE HEAD TO HEAT UP. REPORTED DUE TO THE 2 YEAR PRESUMPTION RULE. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    DURING A STANDARD TREATMENT, AN ELECTRICAL DENTAL HANDPIECE GOT HOT AND CAUSED A BURN ON CHEEK TO THE SIZE OF A QUARTER. THE PT WAS TOLD TO DO WARM, SALT WATER RINSES. 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