BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIET-AIR STANDARD NON FIBER OPTIC

    MDR report key: 392316 · Received April 29, 2002

    Report

    Report Number
    1419322-2002-00018
    Event Type
    Malfunction
    Date Received
    April 29, 2002
    Date of Event
    October 12, 1998
    Report Date
    April 26, 2002
    Manufacturer
    MIDWEST DENTAL PRODUCTS
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTIST ALLEGES THAT A DENTAL BUR AND CHUCK CAME OUT OF THE HANDPIECE TWO TIMES. THE SECOND TIME THEY WERE SWALLOWED BY THE PT. AN X-RAY SHOWED THE BUR AND CHUCK IN THE PT'S STOMACH. THE PT'S PHYSICIAN SAID THERE SHOULD BE NO COMPLICATIONS AND THEY SHOULD PASS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other