BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASTER STANDARD HANDPIECE

    MDR report key: 603558 · Received May 18, 2005

    Report

    Report Number
    2411236-2005-13910
    Event Type
    Other
    Date Received
    May 18, 2005
    Date of Event
    April 12, 2005
    Report Date
    May 18, 2005
    Manufacturer
    NAKANISH, INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    END CAP AND TURBINE OF THE HANDPIECE DETACHED DURING TOOTH PREPARATION. DOCTOR WAS ABLE TO RETRIEVE TURBINE FROM PT'S MOUTH BUT WAS UNABLE TO LOCATE THE END CAP. PT HAD X-RAYS, WHICH CONFIRMED A FOREIGN BODY IN THE PYLORUS. CHILD'S PEDIATRICIAN STATES THAT IT COULD TAKE UP TO 3 MONTHS FOR END CAP TO PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTER STANDARD HANDPIECE DENTAL HANDPIECE EFB NAKANISH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other