BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1033107 · Received April 23, 2008

    Report

    Report Number
    8010493-2008-00006
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 24, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS PRESCRIBED PENICILIN. DOCTOR SENT HANDPIECE TO A LOCAL REPAIR FACILITY, AB TECH, FOR REPAIR. TECHNICIAN FROM REPAIR FACILITY STATED, THE FRONT BEARING WAS WORN AWAY HANDPIECE WAS NOT DENTED. RECEIVED BEARING PARTS FROM REPAIR FACILITY BUT FRONT BEARING WAS MISSING. A CONCLUSION COULD NOT BE MADE WITHOUT RETURN OF ALL COMPONENTS.

    Description of Event or Problem · 1

    THE DOCTOR BURNED A PATIENT ON THE LIP, CHEEK AND TONGUE WITH HANDPIECE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention