BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT 3 MINUTE TABLETS

    MDR report key: 866796 · Received June 15, 2007

    Report

    Report Number
    1020379-2007-00004
    Event Type
    Other
    Date Received
    June 15, 2007
    Report Date
    June 15, 2007
    Manufacturer
    GLAXOSMITHKLINE RTP, NC
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A MALE PT WHO RECEIVED POLIDENT (POLIDENT 3 MINUTE) TABLET FOR AN UNKNOWN DRUG INDICATION. ON AN UNKNOWN DATE, THE PT STARTED POLIDENT, UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING POLIDENT, THE PT EXPERIENCED NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. THE MFR'S REPORT NUMBER FOR THIS CASE IS 1020379-2007-00004. POLIDENT IS MFR, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT 3 MINUTE TABLETS DENTURE CLEANING TABLETS EFT GLAXOSMITHKLINE RTP, NC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other