BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAVO

    MDR report key: 1970168 · Received January 21, 2011

    Report

    Report Number
    MW5019104
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    July 12, 2010
    Report Date
    January 11, 2011
    Manufacturer
    KAVO DENTAL TECHNOLOGIES, LLC
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR REMOVAL OF 5 TEETH INCLUDING 4 IMPACTED 3RD MOLARS. USE OF ELECTRIC HANDPIECE, DESPITE LACK OF PERCEPTABLE HEAT RESULTED IN SEVERE BURNS OF LOWER RIGHT & LEFT LIP ADJACENT TO COMMISSURES. THESE BURNS REQUIRED TREATMENT & WILL REQUIRE PLASTIC REPAIR. ON (B)(6) 2010, PT WITH MOM AND FIANCE, REPORTS IMPROVEMENT BUT WITH OBVIOUS LESIONS LOWER LEFT AND RIGHT LIP ONTO SKIN SURFACE. HOWEVER, NO SIGN OF INFECTION, WOUNDS CLEAN, EXAM OF EXTRACTION SITES WITHIN NORMAL LIMITS. MOM INDICATES THAT PT HAS SEEN DR (B)(6), A DERMATOLOGIST, AND WAS ADVISED THAT PT HAS SECOND DEGREE BURNS, SHE PRESCRIBED A STEROID OINTMENT, AND TOOK BACTERIAL CULTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAVO ORAL SURGICAL HANDPIECE EFB KAVO DENTAL TECHNOLOGIES, LLC INTRAMATIC HANDPIECE 10CH
    2 INTRA LUX 701 MOTOR EFB KAVO DENTAL TECHNOLOGIES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other