BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 3181994 · Received June 14, 2013

    Report

    Report Number
    9681138-2013-00012
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    June 13, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIDENT (DISTRIBUTED AS SUPER POLIGRIP IN THE UNITED STATES) IS MANUFACTURED IN (B)(4), 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 GOVERNMENT BODY ((B)(6) COMPETITION & CONSUMER COMMISSION) AND DESCRIBED THE OCCURRENCE OF IMMOBILITY IN A MALE PT WHO RECEIVED DOUBLE SALT DENTURE CLEANSER (POLIDENT) FOR AN UNKNOWN DRUG INDICATION. ON AN UNKNOWN DATE, THE PT STARTED DOUBLE SALT DENTURE CLEANSER (UNKNOWN), UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTURE CLEANSER, THE PT EXPERIENCED LOST HIS BALANCE AND SUFFERED A SEVERE FALL. THE PT EXPERIENCED BAD BRUISING TO THE BACK AND IMMOBILITY FOR 14 DAYS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTURE CLEANSER WAS DISCONTINUED. AT THE TIME OF REPORTING, THE PT'S BALANCE WAS RESTORED TWO MONTHS AFTER ONSET AND NO INJURY WAS SUSTAINED FROM THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270891 NONE KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other