BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMATIC LUX3 CONTRA ANGLE 25LHA

    MDR report key: 2516512 · Received March 29, 2012

    Report

    Report Number
    3003637274-2012-00017
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    February 14, 2012
    Report Date
    March 5, 2012
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STANDARD DENTAL TREATMENT, THE HAND PIECE HEATED UP AND BURNED THE PT ON THE LOWER RIGHT LIP TO A SIZE OF APPROX 10MM. THE DENTIST DID NOT GIVE OR PRESCRIBE ANYTHING FOR THE BURN. BUT AS PT IS WORKING IN HOSPITAL IN (B)(6), HE WENT TO A PLASTIC SURGEON. DENTAL OFFICE IS NOT AWARE ABOUT THE RESULT OF THE APPOINTMENT. THE ANALYSIS DID SHOW THAT THE BEARINGS HAVE BEEN STIFF AND FALLING APART AND THE WATER SPRAY HAS BEEN CLOGGED. THE HEAD HEATED UP INSTANTLY DURING A TEST RUN. THE HISTORY OF THE PRODUCT SHOWS REPEATED PROBLEMS WITH THE CONDITION OF THE BEARINGS. THIS IS THE RESULT OF THE HANDLING IN THE DENTAL OFFICE AND THE RESULTING STRONGER WEAR. THE USER INSTRUCTION STATES FOLLOWING: DUE TO INCREASE TORQUE AND SPEED, POORLY MAINTAINED, DAMAGED, OR MISUSED HANDPIECES CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PT. THE FOLLOWING GUIDELINES ARE ESSENTIAL FOR THE SAFE OPERATION OF ELECTRIC MICROMOTORS HANDPIECES: TEST RUN HANDPIECE ATTACHMENT, INSPECTING FOR HEAT, EXCESSIVE NOISE OR VIBRATION. IMMEDIATELY STOP USING ANY SUSPECT HANDPIECE. EVENT OCCURRED IN (B)(6), SAME PRODUCT IS SOLD IN THE USA.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HAND PIECE HEATED UP AND BURNED THE PT ON THE LOWER RIGHT LIP TO A SIZE TO APPROX 10MM. THE DENTIST DID NOT GIVE OR PRESCRIBE ANYTHING FOR THE BURN. BUT AS PT IS WORKING IN HOSP IN VANCOUVER HE WENT TO A PLASTIC SURGEON. DENTAL OFFICE IS NOT AWARE ABOUT THE RESULT OF THE APPOINTMENT.

    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 50 YR Other