BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1001059 · Received February 22, 2008

    Report

    Report Number
    8010493-2008-00004
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    February 5, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS PRESCRIBED 800 MG IBUPROFEN. DUE TO IMPROPER MAINTENANCE, BEARINGS WERE WORN AND GRITTY IN DRIVE ASSEMBLY AND SHAFT. BEARINGS FALLING APART. MEDIUM DEBRIS LEVEL. PROPER MAINTENANCE TO HANDPIECE WAS DISCUSSED. REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    BACKCAP OF THE HANDPIECE OVERHEATED AND CAUSED A SMALL BURN TO PATIENT'S LOWER LIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention