BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ULTRA FRESH

    MDR report key: 1559650 · Received December 10, 2009

    Report

    Report Number
    9681138-2009-00189
    Event Type
    Other
    Date Received
    December 10, 2009
    Date of Event
    October 7, 2009
    Report Date
    December 10, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    POLIGRIP EXTRA STRENGTH IS MARKETED UNDER THE TRADE NAME SUPER POLIGRIP ULTRA FRESH IN THE UNITED STATES. POLIGRIP EXTRA STRENGTH IS MANUFACTURED IN (B)(4), AND THE PRODUCT WAS NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BURNING MOUTH IN A (B)(6) FEMALE PT WHO USED POLIGRIP EXTRA STRENGTH (FORMULATION (B)(4)) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO ANTIBIOTIC, ASPIRIN ALLERGY, OSTEOPOROSIS AND SCOLIOSIS. NO CONCURRENT MEDICATION WAS REPORTED. ON (B)(6) 2009, THE PT BEGAN USING POLIGRIP EXTRA STRENGTH (DENTAL). THAT SAME DAY LATER, THE PT EXPERIENCED BURNING MOUTH, WELTS AT SITE (MOUTH), WELTS ON TONGUE, SWOLLEN LIPS, SWOLLEN TONGUE AND MOUTH BLEEDING. POLIGRIP EXTRA STRENGTH WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE IMPROVED. THE PT STATED THE BLEEDING COULD HAVE BEEN DUE TO TRYING TO QUICKLY REMOVE THE PRODUCT. FOLLOW-UP WAS RECEIVED ON (B)(6) 2009. THE PT ONLY USED POLIGRIP EXTRA STRENGTH ON HER LOWER DENTURES. THE PT EXPERIENCED SWOLLEN AND SORE TONGUE AND THROAT FOR MOST OF A WEEK. SHE WAS TREATED WITH CETIRIZINE HC1. THE EVENT HAVE RESOLVED UPON FOLLOW UP RECEIVED (B)(6) 2009, THE PT'S PHARMACIST STATED THE PT'S CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGIC TO PENICILLIN, ALLERGY TO ANTIBIOTIC, ALLERGY TO CEPHALEXIN, ALLERGY TO KETOROLAC, ALLERGY TO METOCLOPRAMIDE, ALLERGY TO QUINIDINE, ALLERGY TO SALICYLATE, ASPIRIN ALLERGY, ALLERGY TO "CHLORPROETHAZINE," ALLERGY TO "SALRVTAMOL," CODEINE ALLERGY, OSTEOPOROSIS, SCOLIOSIS AND TETRACYCLINE ALLERGY. CONCURRENT MEDICATIONS INCLUDED RISEDRONIC ACID (ACTONEL), FXT 40 CALCITRIOL (ROCALTROL), PANTOPRAZOLE, POTASSIUM CHLORIDE (K-DUR), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL), CICLESONIDE (ALVESCO (CICLESONIDE)), GABAPENTIN, NITROGLYCERINE (TRANSDERM NITRO), NITROGLYCERINE (NITROL), FLUOXETINE, BECLOMETHASONE DIPROPIONATE (BECLOMETHASONE), BUDESONIDE, FUCIDIN H, PANCREATIN (CREON 25) AND PANCRELIPASE (COTAZYM). THE PT EXPERIENCED IMMEDIATE DISCOMFORT IN THE MOUTH AFTER APPLYING THE POLIGRIP TO THE LOWER DENTURE. THE PHARMACIST STATED THE PT FELT THIS REACTION TO BE LIFE-THREATENING AND USED HER EPIPEN (ADRENALINE) AND TWO CERTIRIZINE 10 MG. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION, AND THE EVENT LEFT HER MOUTH SORE FOR A WEEK. THIS CASE WAS NOW CONSIDERED AS MEDICALLY SERIOUS BY GSK. THE PHARMACIST FELT THE EVENTS WERE POSSIBLY RELATED TO THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE KOL GLAXOSMITHKLINE X09071A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other PANCRELIPASE| PROPRANOLOL HYDROCHLORIDE| POTASSIUM CHLORIDE| BUDESONIDE| NITROGLYCERINE| CICLESONIDE| CALCITRIOL| NERVE INJURY| NITROGLYCERINE| FLUOXETINE| BECLOMETHASONE DIPROPION| PANCREATION| INJURY| RISEDRONIC ACID| FXT 40| PANTOPRAZOLE| FUCIDIN H| GABAPENTIN