BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFECTIM IMPRESSION SYSTEM

    MDR report key: 470335 · Received July 2, 2003

    Report

    Report Number
    MW1028883
    Event Type
    Other
    Date Received
    July 2, 2003
    Manufacturer
    J. MORITA USA
    Product Code
    ELW
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    USED J. MORITA'S PERFECTIM IMPRESSION SYSTEM (PIS) WITH H&H TECHNIQUE. THE CERTIFIED DENTAL LAB AND CERTIFIED TECHNICIAN WITH 40 YEARS EXPERIENCE FOLLOWED ALL DIRECTIONS FOR TECHNIQUE. NO CROWNS FIT. REPORTER COMPLAINED TO J. MORITA AND THEIR EXPERT SENT THEM TO A DENTAL LAB (NOT CERTIFIED). EXPERT SAID, "CO KNOWS HOW TO USE SYSTEM." AGAIN NOTHING FIT. SENT LETTER TO J. MORITA STATING FACTS AND THEIR SALES MGR RESPONDED TO NONE OF THE ISSUES, BUT SAID IN ESSENCE, REPORTER DOESN'T KNOW WHAT THEY ARE DOING. REPORTER ASKED J. MORITA IF THEY HAVE CLINICAL DATA TO SUPPORT THEIR CLAIMS. THERE WAS NO ANSWER PROVIDED TO THIS QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFECTIM IMPRESSION SYSTEM IMPRESSION MATERIAL ELW J. MORITA USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other