BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1372229 · Received April 28, 2009

    Report

    Report Number
    MW5010899
    Event Type
    Injury
    Date Received
    April 28, 2009
    Date of Event
    October 18, 2008
    Report Date
    April 28, 2009
    Manufacturer
    NA
    Product Code
    ELZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DENTAL CLINIC INSTALLED A NICKEL-WITHOUT DISCLOSURE- CROWN IN MY MOUTH IN 2006. SINCE THEN, IT DEVELOPED SOME SERIOUS PROBLEMS. SOME OF THEM ARE VISIBLE. SUCH AS: MY FACE AND NECK AREA IS ITCHING ALL THE TIME AND SHOWS SOME DARK BROWN MARKS ON THE SKIN; COUGHING NEVER STOPS; PERIODONTAL PROBLEM AROUND CROWN AREA; UNCOMFORTABLE FEELING AROUND KIDNEY AREA. ETC. DATES OF USE: 2006 - 2009. DIAGNOSIS OR REASON FOR USE: COVER BROKEN TOOTH. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NICKEL CROWN ELZ NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R