BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAVO ELECTRO TORQUE

    MDR report key: 841438 · Received April 27, 2007

    Report

    Report Number
    MW5001829
    Event Type
    Other
    Date Received
    April 27, 2007
    Date of Event
    January 1, 2007
    Report Date
    April 23, 2007
    Manufacturer
    KAVO
    Product Code
    EFB
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT HE RECENTLY READ ABOUT THE ELECTRIC HANDPIECE CAUSING BURNS IN THE ADA PROFESSIONAL MAGAZINE. AFTER A DENTAL PROCEDURE WITH THE HANDPIECE, THERE WAS A SMALL WHITE PATCH DETECTED ON A PATIENT'S MOUTH. A FEW DAYS LATER AT FOLLOW-UP, THE SAME LESION WAS THE SIZE OF A QUARTER AND APPEARED TO LOOK LIKE A 'PIZZA WITH CHEESE' ON IT. THE LESION EVENTUALLY WORSENED TO THE POINT THAT THE UNDERLYING ARTERIES BECAME EXPOSED. SHE WAS REFERRED INITIALLY TO AN ORAL SURGEON WHO COULDN'T FIGURE OUT WHAT HAD HAPPENED. A FOLLOW UP CALL TO THE PATIENT'S HOME ELICITED INFORMATION FROM HER SPOUSE THAT SHE'D BEEN TO A PLASTIC SURGEON, WHO'D TREATED HER CONDITION WITH SUTURES. PATIENT WAS LOST TO FOLLOW-UP SINCE DURING THIS TIME HER HUSBAND HAD UNDERGONE A QUADRUPLE BYPASS. IT IS ASSUMED THAT FOLLOWING HER TREATMENT BY THE PLASTIC SURGEON, THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAVO ELECTRO TORQUE DENTAL HANDPIECE EFB KAVO

    Patients

    Seq Age Sex Outcome Treatment
    1 YR