BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    757 WORKHORSE HIGHSPEED DENTAL HANDPIECE

    MDR report key: 50949 · Received November 22, 1996

    Report

    Report Number
    MW1010317
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Date of Event
    October 30, 1996
    Report Date
    November 20, 1996
    Manufacturer
    LARES RESEARCH, INC.
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON 10/30/96 DR WAS TREATING A PT FOR A ROUTINE CROWN PROCEDURE AND THE DENTAL HANDPIECE BROKE IN HALF. A 4-5" METAL TUBING FELL INTO THE PT'S MOUTH AND THE HEAD OF THE DRILL WITH A DIAMOND BURR IN PLACE JUMPED FORWARD. THERE WAS NO APPARENT INJURY TO THE PT, HOWEVER THIS IS THE SECOND NEAR INJURY RPTR HAS EXPERIENCED WITH THIS MODEL OF DENTAL DRILL AND FEELS A NEED TO REPORT THIS INCIDENT. RPTR REPORTED THE FIRST INCIDENT ON 12/1/95 TO THE MFR, WHO ASSURED RPTR THAT THIS WAS A RARE OCCURRENCE. THE HANDPIECES WERE MFG IN 1991 AND RPTR FEELS THERE IS A DESIGN FLAW AND THIS MAY BE DANGEROUS TO PTS. MOST DENTISTS USE THESE DRILLS FOR MANY YEARS AND REPLACE AIR TURBINES PERIODICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 757 WORKHORSE HIGHSPEED DENTAL HANDPIECE HIGHSPEED DENTAL HANDPIECE EFB LARES RESEARCH, INC. LARES 757 WORKHORSE *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other