BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMINEERS

    MDR report key: 1067417 · Received June 27, 2008

    Report

    Report Number
    MW5007451
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    June 21, 2007
    Report Date
    June 27, 2007
    Manufacturer
    LUMINEER
    Product Code
    EBG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD 19 CAPS MADE BY A LUMINEER LAB USING CERINATE MATERIAL. THIS LAB WAS SELECTED BY THE DENTIST. THIS LAB ALSO MADE THE CAPS INCORRECTLY THE FIRST TIME AND HAD TO RE-DO THE CAPS AS REQUESTED BY THE DOCTOR AND PT. THE CERINATE HAS PROVEN TO BE FAULTY IN ITS FUNCTION AND DURABILITY AS A TOOTH CAP. NUMEROUS COMPLAINTS HAVE BEEN REPORTED TO THE DENTIST, A LUMINEER SPECIALIST. TWO ROOT CANALS, ON 2 DIFFERENT OCCASIONS, HAVE HAD TO BE PERFORMED ON 2 DIFFERENT TEETH, BOTH COVERED BY A LUMINEER CAP. IT HAS BEEN REPORTED BY TELEVISION THAT CERINATE HAS BEEN FOUND TO BE FAULTY AS REPORTED IN THE NEWS, 2008. THE MFR, LUMINEER, INC. HAS BEEN CONTACTED AS WELL. I NEED YOUR HELP. LUMENEER CAPS ON 19 TEETH. DATES OF USE: 2007 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINEERS CERINATE MATERIAL BY LUMINEER EBG LUMINEER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Other