BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIET-AIR L FIBER OPTIC

    MDR report key: 392245 · Received April 29, 2002

    Report

    Report Number
    1419322-2002-00020
    Event Type
    Malfunction
    Date Received
    April 29, 2002
    Report Date
    April 26, 2002
    Manufacturer
    MIDWEST DENTAL PRODUCTS
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTIST ALLEGES THAT THE LATCH ON THE DENTAL HANDPIECE DID NOT SEEM TO WORK AND THAT THE DENTAL BUR CAME OUT IN THE PT'S MOUTH. THE BUR WAS RETRIEVED AND THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIET-AIR L FIBER OPTIC DENTAL HANDPIECE EFB MIDWEST DENTAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other