BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1368883 · Received April 27, 2009

    Report

    Report Number
    8010493-2009-00007
    Event Type
    Injury
    Date Received
    April 27, 2009
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PENICILLIN WAS PRESCRIBED TO THE PATIENT FOR TREATMENT OF THE BURN. THE HANDPIECE WAS SENT IN FOR EVALUATION. AT THE EVALUATION, IT WAS FOUND THAT THE TOP OF THE HANDPIECE WAS DENTED AT THE BACK CAP. THE DENT WAS CAUSING THE BACK CAP TO BE DEPRESSED WHICH CAUSED THE HANDPIECE TO OVERHEAT. A REPLACEMENT HANDPIECE WAS SENT TO THE DOCTOR.

    Description of Event or Problem · 1

    THE DOCTOR WAS WORKING ON BRIDGE TOOTH #7 THEN NOTICED A BURN ON THE PATIENT¿S CHEEK AND TONGUE. BURN DIAMETER WAS DIME SIZE ON THE CHEEK AND LARGER THEN QUARTER SIZE ON THE TONGUE.

    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