BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIET-AIR L NON FIBER OPTIC

    MDR report key: 392305 · Received April 29, 2002

    Report

    Report Number
    1419322-2002-00011
    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
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A DENTIST WAS PREPARING A TOOTH FOR A CROWN AND ALLEGED THAT THE BUR CAME OUT OF HIS HANDPIECE AND WAS SWALLOWED BY THE PT. IT WAS A BROKEN BUR. THE PT WAS X-RAYED AND THE BUR WAS OBSERVED IN THE ABDOMEN WITH OTHER PIECES OF AMALGAM (WHICH IS NORMAL). THE MEDICAL DR ALLEGED THAT EVERYTHING LOOKED NORMAL IN THE PT'S ABDOMEN. FOLLOW-UP WITH THE DR REVEALED THAT THE PT PASSED THE BUR WITH NO COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other