BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYTIN AMALGAM

    MDR report key: 307836 · Received December 5, 2000

    Report

    Report Number
    MW1020543
    Event Type
    Malfunction
    Date Received
    December 5, 2000
    Report Date
    December 5, 2000
    Manufacturer
    KERR CORP.
    Product Code
    EJJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS FIRST REPORTED TO USAF DENTAL INVESTIGATION SERVICED IN 8/97 THAT AMALGAM CAPSULES FROM THE KERR CORP WERE LEAKING MERCURY DURING THE TRITURATION OF THE CAPSULES. A PROBLEM RESOLUTION AND ASSISTANCE PROGRAM WAS INITIATED WITH MANY FEDERAL DENTAL FACILITIES OFFICIALLY REPORTED THIS PROBLEM. DIS LAB TESTING CONFIRMED THESE REPORTS. DATA RECEIVED BY DIS SUGGESTS THAT THIS FINDING HAS BEEN AN ONGOING PROBLEM FOR MANY YEARS WITH THESE AMALGAM CAPSULES. KERR CORP ATTEMPTED A CAPSULE MODIFICATION IN 1997 BUT THIS CHANGE DID NOT STOP THE MERCURY LEAKAGE PROBLEM. A NEW CAPSULE HAS BEEN RECENTLY MARKETED BY KERR THAT HAS BEEN SHOWN NOT TO LEAK MERCURY BY DIS TESTING. HOWEVER, MANY OLD KERR AMALGAM CAPSULES ARE STILL IN THE FEDERAL SVC INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYTIN AMALGAM DENTAL AMALGAM CAPSULES EJJ KERR CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 1) TYTIN FC AMALGAM.| 2) COUNTOUR AMALGAM