BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPZC 13-14 CURETTE

    MDR report key: 4456932 · Received January 20, 2015

    Report

    Report Number
    1000127001-2014-00001
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    November 30, 2014
    Report Date
    January 16, 2015
    Manufacturer
    AMERICAN EAGLE INSTRUMENTS, INC.
    Product Code
    EKT
    PMA / PMN Number
    CLASS I EX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS NOT ABLE TO INTERVIEW THE CUSTOMER/END-USER WHO WAS WORKING WITH THE PRODUCT WHEN THEY EXPERIENCED THE EVENT. I HAD VERY LIMITED INFO AVAILABLE TO ME. A 4+ YEAR OLD DENTAL HAND INSTRUMENT (SPECIFICALLY A CURETTE WITH A LIFE EXPECTANCY OF 6-12 MONTHS) WAS BEING USED ON A PATIENT'S MOUTH (UNSURE OF THE EXACT PROCEDURE BEING PERFORMED) WHEN THE POINT OF THE INSTRUMENT (THE WORKING PORTION) CAME OUT OF THE INSERT (A COMPONENT OF THE HANDLE PORTION OF THE INSTRUMENT WHICH JOINS THE POINT TO THE HANDLE) AND LODGED IN THE PATIENTS THROAT. THE LOOSE POINT WAS REMOVED RESULTING IN 'MINOR' INJURY TO THE PATIENT. THERE WAS NO INDICATION OF WHAT ACTION OR ACTIVITY TOOK PLACE OR WAS TAKING PLACE TO CAUSE THE POINT TO COME OUT OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47453 XPZC 13-14 CURETTE UNIVERSAL CURETTE EKT AMERICAN EAGLE INSTRUMENTS, INC. XPZC13-14 0IB

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention