BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROTORQUE PLUS

    MDR report key: 617485 · Received June 24, 2005

    Report

    Report Number
    1419798-2005-00003
    Event Type
    Injury
    Date Received
    June 24, 2005
    Date of Event
    March 1, 2005
    Report Date
    March 28, 2005
    Manufacturer
    KAVO DENTAL
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT A PAT RECEIVED A BURN ON THE INSIDE OF THEIR CHEEK DURING THE USE OF A 25CHA HANDPIECE. IT WAS REPORTED THAT THE BURNED AREA APPEARED WHITE IN COLOR. THE PT WAS ADMINISTERED ANTIBIOTICS (ROUTE AND DOSE UNKNOWN) AND AN UNKNOWN OINTMENT WAS APPLIED TO THE BURN. IT WAS REPORTED THAT THE PT HAS SINCE RECOVERED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE DR HAD USED THE HANDPIECE TO RETRACT THE PT'S CHEEK WHILE DRILLING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other