BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALBERTSONS ANTIBACTERIAL DENTURE CLEANSER

    MDR report key: 2367225 · Received December 5, 2011

    Report

    Report Number
    1219540-2011-00012
    Event Type
    Other
    Date Received
    December 5, 2011
    Date of Event
    November 29, 2011
    Report Date
    December 5, 2011
    Manufacturer
    TOWER LABORATORIES, LTD.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT SHE USED (B)(4) BRAND DENTURE CLEANSING TABLETS AS DIRECTED ON THE BOX WHICH IS ONE TABLET, AND THE ONE TABLET DOES NOT CLEAN HER DENTURES. SO SHE BEGAN DISSOLVING TWO TABLETS TO CLEAN THEM. (B)(6) STATED SHE HAS BEEN USING TWO TABLETS SINCE SHE PURCHASED THE PRODUCT ON (B)(6) 2011. SHE WOKE UP ON (B)(6) 2011 AND THE INSIDE OF HER MOUTH IS PEELING AND HER TONGUE IS SWOLLEN. SHE CANNOT PUT HER DENTURES IN, AND BELIEVES SHE MAY NEED TO SEE A DENTIST. SHE STATED THAT THE PEELING ON THE INSIDE OF THE CHEEKS IS SIMILAR TO A SUNBURN LIKE PEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBERTSONS ANTIBACTERIAL DENTURE CLEANSER EFFERVESCENT DENTURE CLNR EFT TOWER LABORATORIES, LTD. 10905-5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other