BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP FLAVOR FREE

    MDR report key: 2358047 · Received November 28, 2011

    Report

    Report Number
    9681138-2011-00254
    Event Type
    Other
    Date Received
    November 28, 2011
    Date of Event
    October 30, 2011
    Report Date
    November 28, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    POLIGRIP IS MFG IN (B)(4) AND IS DISTRIBUTED AS SUPER POLIGRIP IN THE UNITED STATES. NEITHER THE PRODUCT NOR LOT NUMBER FOR THE PRODUCT ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BLURRED VISION IN A FEMALE PT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (POLIGRIP ULTRA DENTURE ADHESIVE CREAM) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED GLAUCOMA AND ALLERGIES TO MEDICINES. THE PT WAS ONLY ABLE TO USE NATURAL PRODUCTS. ON AN UNK DATE, THE PT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM. AT AN UNK TIME AFTER STARTING TRIPLE SALT DENTAL ADHESIVE CREAM, THE PT EXPERIENCED BLURRED VISION. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. FOLLOW-UP INFO RECEIVED ON (B)(4) 2011, WHICH UPGRADED THE CASE TO MEDICALLY SERIOUS: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BLURRED VISION IN A (B)(6) FEMALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIGRIP FLAVOR FREE) CREAM OVER A PERIOD OF 12 DAYS FOR DENTURES. ADHESION A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY, CHEMICAL ALLERGY, CLOUDING OVER ON EYES, GLAUCOMA, ITCHY SKIN WITH CHEMICAL USE AND SHE WAS ALSO REGISTERED BLIND. CONCURRENT MEDICATIONS INCLUDED EYE MEDICATION (EYE DROPS). ON (B)(6) 2011, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL) DAILY. THE PT IS BLIND IN HER LEFT EYE BUT CAN STILL SEE THROUGH HER RIGHT EYE ALTHOUGH IT IS BLURRY. APPROX 3 DAYS LATER, ON (B)(6) 2011, THE PT EXPERIENCED AN INCREASE IN HER BLURRY VISION WHICH INCREASED SO MUCH THAT SHE COULD RARELY SEE THROUGH THE HEAVY MIST CREATED OVER HER EYE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE PT STATED THAT SHE COULD SEE EVEN LESS NOW AND HAD TRIED TO SEEK A NON-CHEMICAL ADHESIVE BUT NO ONE COULD HELP HER FIND ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP FLAVOR FREE DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other EYE DROPS