BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT OVERNIGHT WHITENING TABLET

    MDR report key: 4093169 · Received September 9, 2014

    Report

    Report Number
    MW5038186
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED ON ((B)(6) 2014) A NEW 84 TABLET BOX OF POLIDENT ANTIBACTERIAL DENTURE CLEANSER, OVERNIGHT WHITENING. STAMP ON TOP CARTON (B)(4). ON (B)(6) 2014 PLACED ONE TABLET AND PARTIAL IN DENTURE SOAK CASE WITH WATER. NEXT MORNING I REMOVED PARTIAL AND RINSED BEFORE PLACING IN MOUTH. BAD TASTE, IMMEDIATELY REMOVED PARTIAL AND RINSED MOUTH WITH CLEAN WATER SEVERAL TIMES. UPPER LIP SWELLED AND NUMB FUZZY FEELING LIP. RINSED AND SOAKED PARTIAL IN FRESH WATER BEFORE PLACING IN MOUTH AGAIN. FIRST TIME I HAVE USED POLIDENT. USED EFFERENT FOR YEARS NO PROBLEM. TRIED TO CONTACT POLIDENT MANUFACTURER; PUT ON HOLD OVER 10 MINUTES. I DO NOT TAKE ANY MEDICATIONS. DOSE OR AMOUNT: ONE TABLET. FREQUENCY: ONCE DAILY. ROUTE: DENTURE CLEANER. DATE OF USE: (B)(6) 2014 - (B)(6) 2014. DIAGNOSIS OR REASONS FOR USE: CLEAN DENTURE PARTIAL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556277 POLIDENT OVERNIGHT WHITENING TABLET DENTURE CLEANSER EFT GLAXOSMITHKLINE MF141413B

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability