BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMATIC LUX3 CONTRA ANGLE 25LHA

    MDR report key: 1912367 · Received November 19, 2010

    Report

    Report Number
    3003637274-2010-00044
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 3, 2010
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 GOT HOT AND PT RECEIVED A SMALL BURN ON CHEEK. DURING PRODUCT EVAL WAS FOUND THAT BEARINGS ARE GRITTY AND FALLING APART. THIS CAUSE THE HANDPIECE TO HEAT UP. HANDPIECE DID NOT GET A REPAIR SINCE 05/2004. (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 HANDPIECE GOT HOT AND PT RECEIVED A SMALL BURN ON CHEEK. TWO PTS HAVE BEEN BURNED IN THE SAME WAY.

    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