BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP COMFORT SEAL STRIP

    MDR report key: 2222589 · Received August 16, 2011

    Report

    Report Number
    3004699328-2011-00003
    Event Type
    Other
    Date Received
    August 16, 2011
    Report Date
    August 15, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP COMFORT SEAL STRIPS ARE MANUFACTURED IN (B)(4). WHILE THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SORE MOUTH IN A (B)(6) FEMALE PT WHO REC'D TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DIABETES. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM, SUPER POLIGRIP (VARIANTS UNK) AND SUPER POLIGRIP COMFORT SEAL STRIPS. IN 2010, THE PT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM AND DOUBLE SALT DENTAL ADHESIVE CREAM. AT AN UNK TIME AFTER STARTING TRIPLE SALT DENTAL ADHESIVE CREAM, THE PT EXPERIENCED SORE MOUTH, INSIDE OF MOUTH BLACK, RASH-LIKE SORES IN MOUTH, SORE LIPS, JAWS AND TONGUE, BUMPS ON ROOF OF MOUTH ("ON THE TOP OF MY MOUTH", SWOLLEN MOUTH, ITCHING ON ARMS, KNOTS ON SKIN OF ARM, AND SWELLING UNDER THE SKIN ON HER ARMS AND THE SKIN ON THE BACK OF HER NECK. THE PT ALSO STATED THAT SHE WAS IN RENAL FAILURE AND HIGH COPPER AND ZINC LEVELS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH TRIPLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. THE CONSUMER REPORTED THAT HER MOUTH TURNED BLACK WHICH WAS CODED AS MOUTH DISCOLORATION. THE CONSUMER REPORTED KNOTS ON HER ARM. THE CONSUMER REPORTED THAT SHE USED THESE PRODUCTS AT THE END OF LAST YR, 2010, AND DISCONTINUED USE A FEW MONTHS BACK BUT WAS UNABLE TO REPORT THE EXACT DATES. THE CONSUMER REPORTED USING OTHER TUBES OF SUPER POLIGRIP (VARIANTS(S) UNK) AND EXPERIENCING THE SAME ADVERSE EVENTS BUT HAD THROWN THE TUBES OUT. THE VARIANTS, LOT NUMBERS ARE NOT AVAILABLE AND THE VARIANT(S) WILL NOT BE RETURNED FOR QUALITY ASSURANCE TESTING). IN 2011, THE PT STARTED USING POLYETHYLENE OXIDE + SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) FOR DENTURE ADHESION. THE PT STATED "WHEN I STARTED USING THE STRIPS MY MOUTH STARTED SWELLING BACK UP." AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP COMFORT SEAL STRIP DENTURE ADHESIVE STRIP KOL GLAXOSMITHKLINE 7K0705

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SUPER POLIGRIP (ORIGINAL, FREE AND UNK)| (SEE MFR REPORT NUMBER 9681138-2011-00198).