BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTURE CLEANSER TABLETS

    MDR report key: 3060445 · Received April 11, 2013

    Report

    Report Number
    1020379-2013-00004
    Event Type
    Other
    Date Received
    April 11, 2013
    Report Date
    April 10, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT DENTURE CLEANSER TABLETS ARE MANUFACTURED IN (B)(4) AND NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A MEMBER OF HOSPITAL EMERGENCY STAFF AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL INGESTION IN A PATIENT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT DENTURE CLEANSER TABLETS) FOR AN UNKNOWN DRUG INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED DOUBLE SALT DENTURE CLEANSER (ORAL) AT A TOTAL DAILY DOSE OF 6 TABLET. AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER, THE PATIENT EXPERIENCED ACCIDENTAL INGESTION OF 6 TABLETS DOUBLE SALT DENTURE CLEANSER. THE PATIENT WAS HOSPITALIZED OR TREATED IN EMERGENCY (UNCONFIRMED). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155437 POLIDENT DENTURE CLEANSER TABLETS DOUBLE SALT DENTURE CLEANSER EFT GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization