BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL

    MDR report key: 1914371 · Received November 18, 2010

    Report

    Report Number
    9681138-2010-00393
    Event Type
    Other
    Date Received
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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 LAWYER VIA A COMPLAINT AND DESCRIBED THE OCCURRENCE OF ZINC TOXICITY IN A FEMALE PT WHO USED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. IN 2000, THE PT USED SUPER POLIGRIP ORIGINAL AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP ORIGINAL, THE PT EXPERIENCED ZINC TOXICITY, NERVE INJURY, PAIN IN SPINE, RADIATION ASSOCIATED PAIN, LACK OF COORDINATION, AND INJURY. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. ACCORDING TO THE LEGAL COMPLAINT, THE PT EXPERIENCED ZINC TOXICITY; AND EXTENSIVE NERVE DAMAGE RESULTING IN SEVERE SPINAL PAIN, RADIATING PAIN IN HER ARMS, LEGS, AND NECK; LACK OF COORDINATION; AS WELL AS OTHER SEVERE AND PERMANENT INJURIES. THE PT'S NEUROLOGICAL INJURIES WERE CONSIDERED "PROFOUND AND PERMANENT." FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ACCORDING TO MEDICAL RECORDS, THE PT HAD A HISTORY OF GUILLAIN-BARRE SYNDROME (GBS) DIAGNOSED IN 1984 AND CANCER OF THE CERVIX (2000). ON (B)(6) 2010, THE PT WAS SEEN BY NEUROLOGY WITH COMPLAINTS OF LOWER BACK PAIN, PROXIMAL MUSCLE PAIN, AND NUMBNESS IN HER HANDS AND FEET FOR ONE MONTH. THE PT REPORTED HER SYMPTOMS STARTED ALL OF A SUDDEN. THE PT STARTED HAVING DIFFICULTY SWALLOWING AND NECK PAIN AFTER INITIATION OF LEVOTHYROXINE. THE PT WAS SEEN IN THE EMERGENCY DEPT ON (B)(6) 2009 FOR EVAL OF DISTAL NUMBNESS AND HEADACHE. COMPUTED TOMOGRAPHY (CT) OF THE HEAD WAS NEGATIVE FOR ANY ACUTE INTRACRANIAL PATHOLOGY. THE PT REPORTED HER SYMPTOMS RESEMBLED PREVIOUS ATTACK OF GUILLAIN BARRE, BUT SHE WAS WEAKER. ASSESSMENT INCLUDED MYALGIA AND MYOSITIS. LUPUS WAS RULED OUT. ON (B)(6) 2010, THE PT REPORTED TERRIBLE BACK PAIN. THE PT ALSO COMPLAINED OF PAIN IN LEGS AND LEGS FEELING "HEAVY." THE PT USED A CANE TO WALK. THE PT COMPLAINED OF "PINS AND NEEDLES" IN HER ARMS AND LEGS, EYESIGHT BLURRY, FORGETFULNESS, DECREASED VOCABULARY, TREMORS IN HANDS AND HEAD, MUSCLE TWITCHES OF TOES AND FINGERS, DIZZINESS, MUSCLE STIFFNESS, SWALLOWING ABNORMALITIES, URINATION PROBLEMS, PAIN IN KNEES, AND INABILITY TO REACH AN ORGASM. ON (B)(6) 2010, IT WAS REPORTED THE PT HAD A NEGATIVE ELECTROMYOGRAPHY (EMG) STUDY. THE PT HAD PARESTHESIAS, CONSTANT TINGLING, AND POOR MEMORY. THE PT'S ZINC LEVEL WAS 206 (NORMAL 60 TO 130 MCG/DL) AND COPPER LEVEL WAS 77 (NORMAL 70 TO 175 MCG/DL). ON (B)(6) 2010, THE PT REPORTED FALLING DOWN STEPS, CAUSED BY "SHOOTING PAIN" IN HER BACK. ASSESSMENT INCLUDED CHRONIC PAIN, PARESTHESIAS, AND INCREASED ZINC LEVEL. NEUROLOGY FOLLOW UP RECOMMENDED. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS PER GSK. ON (B)(6) 2010, IT WAS NOTED THE PT APPEARED TO HAVE MYELONEUROPATHY ON EXAMINATION WITH HYPOACTIVE REFLEXES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT