BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS

    MDR report key: 2543043 · Received April 11, 2012

    Report

    Report Number
    1020379-2012-00004
    Event Type
    Other
    Date Received
    April 11, 2012
    Report Date
    April 10, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS IS 1020379-2012-00004. POLIDENT IS MANUFACTURED IN (B)(4), IN THE UNITED STATES. THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. THE MANUFACTURER'S REPORT NUMBER FOR POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS IS 1020379-2012-00005. POLIDENT IS MANUFACTURED IN (B)(4), IN THE UNITED STATES AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF MOUTH PUCKERED IN A (B)(6) FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS. ON AN UNKNOWN DATE, THE PATIENT STARTED DOUBLE SALT DENTURE CLEANSER. AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER, THE PATIENT EXPERIENCED MOUTH PUCKERED, ORAL DISCOMFORT, TONGUE MOVEMENT IMPAIRED AND ALLERGY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTURE CLEANSER WAS CONTINUED. AT THE TIME OF REPORTING THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED THAT THE EVENTS HAVE BEEN OCCURRING OVER THE LAST 3 MONTHS. CONSUMER REPORTED DIFFICULTY MOVING TONGUE WHICH SHE FURTHER DESCRIBED AS, I FEEL LIKE I CAN'T MOVE MY TONGUE FREELY, BUT IT'S NOT DRY MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA M10811

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other