BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAVO ELECTRO TORQUE PLUS

    MDR report key: 851566 · Received May 18, 2007

    Report

    Report Number
    MW5001867
    Event Type
    Other
    Date Received
    May 18, 2007
    Report Date
    May 16, 2007
    Manufacturer
    KAVO
    Product Code
    DZA
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORTER IS A DENTIST WHO STATES THAT HE HAS HAD TWO OF HIS PTS BURNED FROM THE HANDPIECE. AND, THE MFR FAILS TO WARN THAT IT (THE DEVICE) CAN GET HOT ENOUGH TO BURN A PT! ONE PT SUSTAINED A BURN TO THE TONGUE AND ANOTHER PT SUSTAINED A BURN TO THE LIP. THE BURNS DID NOT REQUIRE ANY MEDICAL INTERVENTION, AS FAR AS HE KNOWS. BOTH PTS ARE NOT UPSET WITH HIM, BUT THE ONE WHO WAS BURNED ON THE LIP WAS UPSET WITH THE MFR. INITIALLY THE BURNS APPEARED ON THE SURFACE TO BE JUST SOME DESQUAMATION OF THE SKIN. HE READ ABOUT A SIMILAR CASE IN WHICH THE BURN TOOK A LONG TIME TO HEAL BECAUSE OF IT'S LOCATION BEING AT THE CORNER OF THE PT'S MOUTH. REPORTER FEELS THAT FDA SHOULD BE HELD MORE ACCOUNTABLE ABOUT THE POSSIBILITY OF ALL HANDPIECES, NOT JUST KAVO'S CAUSING BURNS. HE DOESN'T WANT TO GET KAVO IN TROUBLE, BECAUSE HE BELIEVES THAT THEY ARE A GOOD COMPANY. HE CONTACTED THE MFR FIRST SUGGESTING THAT NOTICES BE SENT OUT ABOUT THE POTENTIAL PROBLEMS. THEY MADE LIGHT OF THE FINDINGS AND THANKED HIM FOR HIS CALL. END OF REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR