BEUDAMED
    FDA Adverse Event Other Summary report: N

    DENTURE CLEANSERS

    MDR report key: 1916814 · Received November 15, 2010

    Report

    Report Number
    MW5018376
    Event Type
    Other
    Date Received
    November 15, 2010
    Report Date
    November 15, 2010
    Product Code
    KOL
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM CONCERNED THAT SAMPLING OF PRODUCTS LIKE THESE, WITHOUT PROPER LABELING AS SUGGESTED BY THE FDA IN ITS (B)(6) 2008 WARNING LETTER POSES A RISK TO PTS. WITHOUT LABELING OF INGREDIENTS IN PRODUCTS LIKE THESE, ADDITIONAL INJURIES AND EVEN DEATHS ARE LIKELY TO OCCUR. FDA ACTIONS: FDA IS RECOMMENDING THAT ALL MFRS OF DENTURE CLEANSERS MODIFY THEIR LABELING TO INCLUDE WARNING INFO THAT THE PRODUCT CONTAINS PERSULFATES, WHICH ARE A KNOWN ALLERGEN, AND TO IMPROVE THE DIRECTIONS FOR USE ON THEIR LABELING IN ORDER TO REDUCE MISUSE. WE ARE ALSO RECOMMENDING MFRS CONSIDER APPROPRIATE ALTERNATIVES TO USE OF PERSULFATES. WE BELIEVE THESE ACTIONS WILL MINIMIZE THE RISK OF ADVERSE REACTIONS. I AM ENCLOSING SAMPLING FROM REGENT LABS, INC, FOR THEIR STAIN AWAY PLUS PROFESSIONAL STRENGTH DENTURE CLEANSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENTURE CLEANSERS DENTURE CLEANSERS KOL

    Patients

    Seq Age Sex Outcome Treatment
    1