BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTGLASS

    MDR report key: 133756 · Received November 15, 1997

    Report

    Report Number
    MW1012523
    Event Type
    Malfunction
    Date Received
    November 15, 1997
    Manufacturer
    KULZER, INC.
    Product Code
    EBG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MFR ON 1/15/98. A CORRECTION TO THE MEDWATCH REPORT IS THAT 'ARTGLASS' IS NOT "CROWN PORCELAIN". IF CO HAD BEEN MADE AWARE OF ANY PROBLEM EXPERIENCED FROM JULY TO OCTOBER OF 1997 AND WERE PROVIDED WITH AS MANY DETAILS AS POSSIBLE, CO WOULD HAVE BEEN ABLE TO ANALYZE IT AND DIRECTLY ASSIST THE USER OF CO PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTGLASS DENTAL RESTORATION EBG KULZER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other