BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAVO

    MDR report key: 1760700 · Received July 13, 2010

    Report

    Report Number
    MW5016727
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 13, 2010
    Manufacturer
    KAVO DENTAL
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    I AM A DENTIST IN (B) (6). ON (B) (6)2010, I COMPLETED A CROWN PREPARATION ON MS. (B) (6) -TOOTH #3 -- UPPER RIGHT QUADRANT-. I USED OUR NEW KAVO COMFORT DRIVE ELECTRIC DENTAL HANDPIECE, WITH COPIOUS WATER IRRIGATION. WHEN I INITIATED THE TOOTH PREPARATION, MS. (B) (6) JUMPED AND SAID "OUCH." SHE SAID THAT SOMETHING HAD BURNED THE INSIDE OF HER CHEEK. EXAMINATION OF THE PT'S RIGHT BUCCAL MUCOSA REVEALED A 1 CM X 1 CM WHITISH PATCH, WHICH SOON DEVELOPED AN ULCERATED CENTER. THE LESION WAS CONSISTENT WITH A MUCOSAL BURN. I STARTED THE HANDPIECE AGAIN IN MY HAND, THIS TIME FEELING THE BACK OF IT WITH MY GLOVED FINGER. ALMOST IMMEDIATELY -WITHIN 5 SECONDS OF RUNNING THE HANDPIECE-, I NOTED THAT THE AUTO-CHUCK AREA OF THE HANDPIECE HEAD WAS VERY HOT. I HAD TO WITHDRAW MY FINGER QUICKLY. INDEED, IT HAD CAUSED A BURN ON THE PT'S BUCCAL MUCOSA. I IMMEDIATELY APPLIED VITAMIN E OIL TO THE BURN SITE, AND REPEATED THIS SEVERAL TIMES THROUGHOUT THE APPOINTMENT. I CHANGED HANDPIECES, AND I WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THE PT WAS ADVISED TO KEEP THE AREA CLEAN AND AVOID CHEWING ON THAT SIDE, SO AS NOT TO FURTHER IRRITATE THE BURN SITE. IT WAS EXPLAINED THAT THE LESION WOULD HEAL ON ITS OWN IN 7-10 DAYS. I PHOTOGRAPHED THE LESION TO KEEP AS PART OF THE PT'S DENTAL RECORD. THE KAVO REP CAME TO THE DENTAL OFFICE A COUPLE OF HOURS LATER TO ACQUIRE THE HANDPIECE IN QUESTION. VISUAL INSPECTION REVEALED A SMALL DENT IN THE HOUSING OF THE HANDPIECE HEAD, ADJACENT TO THE AUTO-CHUCK. HOWEVER, THE AUTO-CHUCK STILL WORKED PROPERLY AND ALLOWED A BUR TO BE PLACED IN IT. FURTHER, THE HANDPIECE STILL RAN WITH THE BUR IN PLACE, BUT GOT BURNING HOT AS IT DID DURING THE PT'S APPOINTMENT. THE KAVO REP TOOK THE HANDPIECE WITH HIM IN ORDER TO SEND IT TO HIS CORPORATE HEADQUARTERS FOR FURTHER INSPECTION AND REPORTING. THE PT WAS CALLED THE FOLLOWING MORNING -(B) (6)2010- AND WAS DOING WELL. A FOLLOW-UP PHONE CALL WAS ALSO MADE FIVE DAYS LATER -(B) (6)2010-, AND SHE REPORTED THAT THE LESION WAS HEALING SLOWLY. SHE WILL BE SEEN IN OUR OFFICE FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAVO COMFORTDRIVE ELECTRIC DENTAL HANDPIECE EFB KAVO DENTAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability