BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMATIC LUX3 CONTRA ANGLE 25LHA

    MDR report key: 1935412 · Received November 11, 2010

    Report

    Report Number
    3003637274-2010-00043
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 11, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 HANDPIECE GETS WARM. THE PT WAS NOT BURNED BY THE HANDPIECE. DURING PRODUCT EVALUATION WAS FOUND, (B)(6) DOES SLIP (RUNS OUT OF SPEC), THE WATER SPRAY HOLES WAS CLOGGED. THE BEARINGS WHERE GRITTY AND THE HEAD OF THE HANDPIECE GET'S WARM NOT HOT.

    Description of Event or Problem · 1

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT USING A DENTAL ELECTRICAL HANDPIECE WHEN THE HANDPIECE GET'S WARM. THE PT WAS NOT BURNED BY THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMATIC LUX3 CONTRA ANGLE 25LHA DENTAL HANDPIECE EFB KAVO DENTAL GMBH 25LHA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention