BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONRA ANGLE 25LPA

    MDR report key: 1871107 · Received October 12, 2010

    Report

    Report Number
    3003637274-2010-00033
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE PT'S TONGUE WAS BURNED BY THE HEAD OF A HANDPIECE. THE PT WAS NOT GIVEN ANY MEDICATION OR OINTMENT, IT HEALED BY ITSELF. DURING PRODUCT EVAL, LOW DEBRIS LEVEL WAS FOUND IN THE HANDPIECE. THE HEAD WAS DENTED AND THE BACK CAP BUTTON STICKS IN/RUBS ON BEARINGS WHICH CAUSED IT TO HEAT UP THE HEAD OF THE HANDPIECE.

    Description of Event or Problem · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE PT WAS BURNED BY THE HEAD OF A HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEPOWER LUX CONRA ANGLE 25LPA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention