BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX HANDPIECE

    MDR report key: 11189 · Received February 2, 1994

    Report

    Report Number
    MW1000560
    Event Type
    Injury
    Date Received
    February 2, 1994
    Date of Event
    December 9, 1993
    Report Date
    January 14, 1994
    Manufacturer
    MTI PRECISION PRODUCTS
    Product Code
    EFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A MINIMAL RISK DENTAL PROCEDURE, ADJUSTING A FILLING (AMALGAM) THE BACK OF A HANDPIECE (DRILL) CAME OFF, WHEREBY THE PT SWALLOWED THE BACKING. FORTUNATELY, A FEW DAYS LATER THE PT PASSED THIS PART OF THE APPARATUS IN A BOWEL MOVEMENT. IT'S IMPERATIVE TO REMEMBER THAT THIS BACKING COULD HAVE EASILY BEEN LODGED IN HER RESPIRATORY SYSTEM (ASPIRATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX HANDPIECE EFA MTI PRECISION PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization