BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIET AIR LEVER NON-FIBER OPTIC

    MDR report key: 531059 · Received March 5, 2004

    Report

    Report Number
    1419322-2004-00115
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 22, 2004
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE HANDPIECE IS NOT HOLDING THE BUR. THE BUR FELL OUT OF THE HANDPIECE WHILE IN USE IN A PT'S MOUTH. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIET AIR LEVER NON-FIBER OPTIC DENTAL HANDPIECE EJL DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other