BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONRA ANGLE 25LPA

    MDR report key: 1912366 · Received November 19, 2010

    Report

    Report Number
    3003637274-2010-00046
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 21, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE WORKING ON THE TOOTH# 12, THE PT'S LOWER LIP WAS BURNED. THE BURN AREA WAS THE SIZE OF HANDPIECE HEAD. THE PT WAS GIVEN SOME MEDICATED VASELINE. THE INJURY DOES HEAL WELL. DURING PRODUCT EVAL, LOW DEBRIS LEVEL WAS FOUND IN THE HANDPIECE. THE BEARINGS WERE GRITTY. THE GRINDING BEARINGS LEAD TO HEAT UP THE HEAD OF THE HANDPIECE. (B)(4). KAVO DENTAL (B)(4) (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE IMPORTER).

    Description of Event or Problem · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE PT'S LOWER LIP WAS BURNED BY THE HEAD OF THE 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