BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 3190958 · Received June 21, 2013

    Report

    Report Number
    9681138-2013-00014
    Event Type
    Other
    Date Received
    June 21, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF TONGUE CHOKING IN AN ELDERLY FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (POLIGRIP) FOR LOOSE DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (DENTAL), UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED TONGUE CHOKING, DRY MOUTH, COATED TONGUE, TASTE SALTY, RUN DOWN FEELING, UNABLE TO SLEEP AT NIGHT DUE TO TASTE IN MOUTH, GAGGING AND TIRED (COULDN'T SLEEP). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-0014. POLIGRIP IS MANUFACTURED IN (B)(4), AND MARKETED AS SUPER POLIGRIP IN THE UNITED STATES. NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282572 POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other