BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QHL75CURING LIGHT

    MDR report key: 333296 · Received May 14, 2001

    Report

    Report Number
    2515379-2001-00004
    Event Type
    Malfunction
    Date Received
    May 14, 2001
    Date of Event
    March 10, 2001
    Report Date
    April 9, 2001
    Manufacturer
    L.D. CAULK
    Product Code
    EAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHEN THE DENTIST REMOVED THE LIGHT FROM CURING A COMPOSITE ON AN UPPER ARCH TOOTH, THE NOSE CONE FELL OFF AND HIT THE PATIENT'S NOSE LEAVING A 12MM LONG CUT ABOUT 2MM DEEP. THE DENTIST WAS ABLE TO CONTROL THE BLEEDING BY APPLYING DIRECT PRESSURE. ACCORDING TO THE DENTIST NO GLASS OR DEBRIS ENTERED THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22637 QHL75CURING LIGHT DENTAL CURING LIGHT EAY L.D. CAULK 506 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other