BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROTORQUE PLUS

    MDR report key: 774606 · Received October 26, 2006

    Report

    Report Number
    1419798-2006-00005
    Event Type
    Injury
    Date Received
    October 26, 2006
    Date of Event
    September 13, 2006
    Manufacturer
    KAVO DENTAL
    Product Code
    DZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL UNIT INVOLVED IN THE INCIDENT WAS RETURNED FOR EVALUATION. THE HEAD OF THE HANDPIECE WAS OBSERVED TO HAVE DENTS IN THE LOCATION OF THE BACK CAP AND WATER SPRAY PLATE. WHILE RUNNING THE HANDPIECE, THE HEAD BECAME HOT DUE TO THE MECHANICAL FRICTION CREATED BETWEEN THE RUNNING GEARS AND THE DENTS IN THE HEAD. THE UNIT WAS DISASSEMBLED FOR FURTHER INSPECTION. VISUAL INSPECTION REVEALED THAT THERE WAS A LIGHT RESIDUE INSIDE THE HANDPIECE. A CAUTIONARY STATEMENT IS INCLUDED WITH EACH UNIT WHICH STATES THAT ELECTRIC MICROMOTORS GENERATE SIGNIFICANTLY MORE POWER THAN TRADITIONAL AIR TURBINES AND AIR MOTORS. DUE TO INCREASED TORQUE AND SPEED, POORLY MAINTAINED, DAMAGED OR MISUSED HANDPIECES CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PATIENT. IT ALSO STATES THAT THE HEAD OF THE ATTACHMENT SHOULD NOT BE USED AS A CHEEK OR TONGUE RETRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD OF A 25LPA HANDPIECE BECAME HOT AND BURNED PATIENT'S CHEEK. THE PATIENT WAS ADMINISTERED ZITHROMAX AND "ZYCOPROFEN" AND WAS INSTRUCTED TO USE PERIDEX ORAL RINSE. DURING A FOLLOW UP CALL WITH THE DOCTOR'S OFFICE BY THE MANUFACTURER ON 10/12/06, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED PAIN/DISCOMFORT FOR 21 DAYS AND THAT THE BURN HAD LEFT AN INDENTATION ON HER CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROTORQUE PLUS ELECTRIC DENTAL HANDPIECE DZA KAVO DENTAL 25LPA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other