BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M RELYX

    MDR report key: 8731317 · Received June 24, 2019

    Report

    Report Number
    MW5087591
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    March 10, 2009
    Report Date
    June 20, 2019
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    EMA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    EVERY TIME I PURCHASE A DENTAL PRODUCT FROM THIS COMPANY, IT'S NEVER THE SAME QUALITY OR CONSISTENCY AS WHAT I RECEIVE FROM DARBY OR HENRY SCHEIN. I SERIOUSLY FEEL LIKE THIS COMPANY IS SELLING COUNTERFEIT OR DAMAGED ITEMS TO THEIR CUSTOMERS. PRODUCT TYPE: OTC. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? YES. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? YES. FREQUENCY: OTHER - DENTAL ITEM. HOW WAS IT TAKEN OR USED? TOPICALLY. REASON FOR USE: ORAL EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523237 3M RELYX CEMENT, DENTAL EMA 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1