BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPA

    MDR report key: 1153363 · Received September 5, 2008

    Report

    Report Number
    8010493-2008-00014
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 13, 2008
    Manufacturer
    KALTENBACH & VOIGT GMBH
    Product Code
    EFA
    PMA / PMN Number
    PRE-AMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS GIVEN VICODIN PAIN RELIEVER AND KENALOG ORABASE. PATIENT HAS HEALED COMPLETELY. THE USER USED THE HANDPIECE AS A CHECK RETRACTOR CAUSING THE HANDPIECE TO OVERHEAT. OFFICE STAFF DID NOT LUBRICATE THE HANDPIECE AS DIRECTED IN THE INSTRUCTIONS FOR USE. DUE TO IMPROPER MAINTENANCE, BEARINGS WERE WORN AND GRITTY IN DRIVE ASSEMBLY AND SHAFT, THE CHUCK WAS SLIPPING, LOW DEBRIS LEVEL WAS PRESENT. PROPER MAINTENANCE TO HANDPIECE WAS DISCUSSED.

    Description of Event or Problem · 1

    PATIENT'S CHEEK WAS BURNED BY THE HANDPIECE WHEN IT WAS USED AS A CHEEK RETRACTOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention