BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMAL CAR. D/E MED/LGE STE

    MDR report key: 2185572 · Received June 9, 2011

    Report

    Report Number
    2523190-2011-00043
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED AND AN INVESTIGATION HAS BEEN COMPLETED. THE ROOT CAUSE OF THE FAILURE WAS THE DEVICE WAS DAMAGED AND WORN. THE LEVER THAT PUSHES THE AMALGAM IN IS BROKEN OFF, THIS COULD HAVE HAPPENED FROM TOO MUCH AMALGAM IN THE CARRIER. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSTRUMENT BROKE APART DURING NORMAL USE IN A PT'S MOUTH. TIP END IS BROKEN. ADDITIONAL INFO OBTAINED ON (B)(6) 2011 FROM DENTAL ASSISTANT WHO STATED THE TIP OF THE INSTRUMENT BROKE INSIDE THE PT'S MOUTH WHEN THE DENTIST USED IT TO INSERT AMALGAM DURING A PROCEDURE. THERE WAS NO INJURY OR HARM TO THE PT BUT THE DENTIST FELT THERE WAS A POTENTIAL FOR HARM AS THE INSTRUMENT'S TIP COULD BE SWALLOWED OR ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMAL CAR. D/E MED/LGE STE M51 - GENERAL DENTISTRY EMJ INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1