BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 1427318 · Received April 1, 2009

    Report

    Report Number
    1020379-2009-00001
    Event Type
    Other
    Date Received
    April 1, 2009
    Report Date
    April 1, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B) (6) FEMALE PT WHO USED DOUBLE SALT DENTURE CLEANSER (B) (4) (POLIDENT DENTURE CLEANSER TABLETS). A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING POLIDENT 3-MINUTE TABLETS, POLIDENT OVERNIGHT TABLETS, AND POLIDENT SMOKER'S TABLETS. AT AN UNK TIME AFTER STARTING USE OF THE PRODUCTS, THE PT EXPERIENCED NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. USE OF THE PRODUCTS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. THE MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2009-00001. POLIDENT DENTURE CLEANSER TABLETS ARE MANUFACTURED, IN (B) (4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DENTURE CLEANSER TABLETS DENTURE CLEANSER TABLETS EFT GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other