BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAIN AWAY FOR PARTIALS

    MDR report key: 596589 · Received April 21, 2005

    Report

    Report Number
    MW1035279
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Report Date
    April 21, 2005
    Manufacturer
    REGENT LABS INC.
    Product Code
    EFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN USING THIS PRODUCT FOR ABOUT 8 YEARS. EACH BATCH SEEMS TO REACT DIFFERENT THAN EVERY OTHER BATCH BEFORE IT. IN SOME CASES THERE ARE BLUE PARTICLES AND SOME TIME THERE ARE NONE. SOME TIMES THE PRODUCT FOAMS BUT MOST OF THE TIME IT DOESN'T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAIN AWAY FOR PARTIALS DENTURE CLEANER EFT REGENT LABS INC. NA NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR