BEUDAMED
    FDA Adverse Event Summary report: N

    STAIN AWAY PLUS

    MDR report key: 2506831 · Received March 22, 2012

    Report

    Report Number
    MW5024776
    Date Received
    March 22, 2012
    Date of Event
    March 20, 2011
    Report Date
    March 22, 2012
    Manufacturer
    REGENT LABS INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED STAIN AWAY PLUS DENTURE AND PARTIAL CLEANSER, MANUFACTURED BY REGENT LABS INC (B)(4). IT STATES CLEARLY ON THE BOX IT IS SAFE TO USE ON ALL PARTIALS AND DENTURES ON A DAILY BASIS. I USED ONE CAPFUL OF THIS POWDER TO SOAK MY PARTIALS AND THE PINK AREA OF MY PARTIALS WAS COMPLETELY DESTROYED AND BLEACHED WHITE. THE COST TO REPAIR MY PARTIALS IS OVER (B)(6). I CONTACTED THE COMPANY TO ASK THE INGREDIENTS IN THIS PRODUCT AND THEY CLAIM IT IS THE SAME AS POLIDENT AND WILL NOT DISCLOSE THE INGREDIENTS. MY DENTIST HAS THE PRODUCT IN HIS POSSESSION AND IS CURRENTLY ANALYZING THE INGREDIENTS FOR SAFETY. MY PARTIALS ARE MADE OF HIGH QUALITY LUCITONE 199. THIS PRODUCT IS DEFECTIVE, DANGEROUS TO THE CONSUMER AND NEEDS TO BE PULLED OFF THE SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAIN AWAY PLUS DENTURE CLEANER EFT REGENT LABS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R