BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1349193 · Received March 24, 2009

    Report

    Report Number
    8010493-2009-00004
    Event Type
    Injury
    Date Received
    March 24, 2009
    Report Date
    January 11, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PRESCRIBED 800MG IBUPROFEN AND AMOXICILLIN. PATIENT WAS SEEN TWO WEEKS LATER AND WAS HEALING. DURING HANDPIECE EVALUATION, IT WAS FOUND THAT THE BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY AND SHAFT. LOW DEBRIS WAS PRESENT. THE DOCTOR REQUESTED THAT THE HANDPIECE BE REPLACED. REPLACEMENT HANDPIECE WAS SENT.

    Description of Event or Problem · 1

    THE HANDPIECE HEATED UP AND A PATIENT WAS BURNED ON THE CHEEK.

    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