BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1199623 · Received October 20, 2008

    Report

    Report Number
    8010493-2008-00020
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2006
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS GIVEN A TOPICAL ANAESTHETIC GEL IN THE OFFICE AND CONTINUED TO USE PARIOGUARD RINSE AT HOME. THE DOCTOR STATED THAT THE PATIENT HAS HEALED FINE.AT THE HANDPIECE EVALUATION, IT WAS FOUND THAT THE HEAD WAS DENTED AND THE BACKCAP WAS STUCK IN, CAUSING THE HEAD OF THE HANDPIECE TO HEAT UP.A REPLACEMENT HANDPIECE WAS SENT TO THE DOCTOR'S OFFICE.

    Description of Event or Problem · 1

    WHILE THE DENTIST WAS WORKING ON THE LOWER RIGHT TEETH, THE PATIENT'S CHEEK WAS BURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention