BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2111207 · Received May 26, 2011

    Report

    Report Number
    9681138-2011-00133
    Event Type
    Other
    Date Received
    May 26, 2011
    Report Date
    May 25, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MFG IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT, AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A MALE PT WHO USED POLIGRIP DENTURE ADHESIVE CREAM (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING POLIGRIP. AT AN UNK TIME AFTER STARTING POLIGRIP, THE PT EXPERIENCED "NEUROLOGICAL INJURIES" (NERVE INJURY). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. F/U INFO WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2004, THE PT HAD A HISTORY OF NUMEROUS ORTHOPEDIC SURGERIES, INCLUDING: CARPAL TUNNEL SYNDROME, TRIGGER FINGER RELEASE, CUBITAL TUNNEL SYNDROME SURGERY, LEFT SHOULDER SURGERY WITH ROTATOR CUFF REPAIR, AND LEFT ELBOW NERVE TRANSPOSITION SURGERY. THE PT WAS EVALUATED FOR DRUG DEPENDENCY. ON (B)(6) 2004, IT WAS NOTED THE PT HAD DRUG DEPENDENCY AS A RESULT OF CHRONIC PAIN FROM NUMEROUS NECK, SHOULDER, ELBOW, AND WRIST SURGERIES. ON (B)(6) 2005, IT WAS NOTED THE PT WAS STATUS POST NERVE TRANSPOSITION SURGERY ON THE LEFT ARM. ON (B)(6) 2006, THE PT WAS STATUS POST MOTOR VEHICLE ACCIDENT ((B)(6) 2006) WITH POSSIBLE POST CONCUSSIVE SYNDROME WITH HEADACHES AFTER LOSING CONSCIOUSNESS DURING A MOTOR VEHICLE ACCIDENT. ON (B)(6) 2007, ASSESSMENT INCLUDED CERVICAL DISC DISEASE AND CHRONIC NECK PAIN AFTER MOTOR VEHICLE ACCIDENT. ON (B)(6) 2009, THE PT WANTED TO TALK ABOUT GETTING A ZINC LEVEL CHECKED TO SEE IF HE HAD ZINC TOXICITY, AFTER READING ON THE COMPUTER ABOUT ZINC POISONING FROM POLIGRIP AND FIXODENT. ON (B)(6) 2009, THE PT HAD SUFFERED SOME WEAKNESS AND FATIGUE AND HAD BEEN CONCERNED ABOUT HEAVY METAL TOXICITY BECAUSE HE HAD A SLIGHTLY ELEVATED SINGLE LEVEL AND HE HAD BEEN USING A LOT OF POLIGRIP FOR HIS DENTURES. ON (B)(6) 2009, THE PT CONTINUED TO BE CONCERNED ABOUT EXPOSURE TO ZINC IN HIS DENTURE ADHESIVE. AS A RESULT OF A ZINC EXPOSURE, HE WAS THINKING HE MIGHT HAVE HAD ELEVATED LEVELS OF ZINC AND SUBSEQUENT COPPER DEFICIENCY AND MIGHT BE EXPERIENCING SOME NEUROLOGIC CONSEQUENCES BECAUSE OF THAT. HIS MAIN SYMPTOMS WERE SYMPTOMS OF FLASHING LIGHTS THAT HE SAW IN HIS PERIPHERY OF HIS VISION, NUMBNESS IN HIS EXTREMITIES, AND OCCASIONAL MUSCLE SPASMS IN HIS ARMS AND LEGS. HE WAS SEEN BY A NEUROLOGIST IN THE 1980'S WHO TOLD HIM HE MIGHT HAVE A TENDENCY TOWARDS A SEIZURE DISORDER, BUT HE HAD NOT SEEN A NEUROLOGIST SINCE THEN. ASSESSMENT INCLUDED ZINC TOXICITY WITH LOW LEVELS OF COPPER. THE LATEST LABS WERE COMPLETED IN (B)(6) 2009. THE PT CONTINUED TO USE THE DENTURE ADHESIVE. THE PT WAS ENCOURAGED TO STOP USING THE PRODUCT. ON (B)(6) 2010, IT WAS NOTED THE PT WAS ON DISABILITY FOR CHRONIC BACK PAIN. THE PT NOW COMPLAINED OF SOME NUMBNESS IN HIS RIGHT LEG, MIGRAINE TYPE AURA SYMPTOMS INCLUDING DISORDER OF SMELL, VISION, AND SOME NUMBNESS AND NECK PAIN. F/U INFO WAS RECEIVED ON (B)(6) 2011 VIA FACT SHEETS SENT BY THE PT AND/OR PT'S ATTORNEY. THE PT EXPERIENCED NEUROPATHY, A BURNING SENSATION IN HIS THIGHS, INCREASE IN MIGRAINES, PAINFUL JOINTS (SOMETIMES SWOLLEN), AND FELT TIRED AND CONFUSED ALL THE TIME. THE PT FIRST USED UPPER AND LOWER DENTURES IN (B)(6) 1998. SUPER POLIGRIP ORIGINAL WAS USED FROM (B)(6) 1998 UNTIL (B)(6) 2009, TWO TO THREE TIMES A DAY, ONE TO TWO 2.4 OUNCE TUBES. THE PT CURRENTLY USED POLIGRIP ZINC FREE. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other