BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1233984 · Received November 19, 2008

    Report

    Report Number
    8010493-2008-00022
    Event Type
    Injury
    Date Received
    November 19, 2008
    Report Date
    October 22, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PRESCRIBED SILVER SULFADIAZINE TO APPLY TO BURN ON LIP. THE PATIENT COMPLETELY HEALED. AT THE HANDPIECE EVALUATION, IT WAS FOUND THAT THE HEAD WAS DENTED, THE BEARINGS WERE GRINDING, AND THE HEAD WAS HEATING UP. LOW RESIDUE LEVEL WAS PRESENT. THE OFFICE WAS INFORMED THAT THE DENT IN THE HEAD WAS CAUSING IT TO OVERHEAT. THE HANDPIECE WAS REPAIRED.

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS WORKING ON TOOTH #22 AND #23, THE PATIENT'S LIP WAS BURNED ABOUT THE SIZE OF A DIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONTRA ANGLE 25LPA DENTAL HANDPIECE AND ACCESSORIES EFB KALTENBACH & VOIGT GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention