BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT TABLETS (FORMULATION UNKNOWN)

    MDR report key: 2213982 · Received August 1, 2011

    Report

    Report Number
    1020379-2011-00012
    Event Type
    Other
    Date Received
    August 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT IS MANUFACTURED IN (B)(4) IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR 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 STROKE IN A PT WHO REC'D DOUBLE SALT DENTURE CLEANSER (B)(4) (POLIDENT) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED DOUBLE SALT DENTURE CLEANSER (B)(4), UNK DOSING. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER (B)(4), THE PT EXPERIENCED STROKE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT TABLETS (FORMULATION UNKNOWN) DOUBLE SALT DENTURE CLEANSER MFC50075 EFT GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other