BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2111055 · Received May 19, 2011

    Report

    Report Number
    9681138-2011-00124
    Event Type
    Other
    Date Received
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED 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 AND DESCRIBED THE OCCURRENCE OF ZINC TOXICITY IN A FEMALE, PT, WHO USED SUPER POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) AND FIXODENT. IN 1999, THE PT USED SUPER POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP, THE PT EXPERIENCED "ZINC TOXICITY, NERVE DAMAGE, DIZZINESS, TINGLING OF EXTREMITY, NUMBNESS OF EXTREMITIES, BURNING OF EXTREMITIES, PAIN IN EXTREMITY, AND WEAKNESS IN EXTREMITY. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. 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 DIZZINESS, TINGLING, NUMBNESS, BURNING, PAIN, WEAKNESS TO HER HANDS, ARMS, LEGS AND FEET." THE PT "SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES INCLUDING, BUT NOT LIMITED TO, PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." IT WAS FURTHER REPORTED THE PT'S "INJURIES AND DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE." FOLLOW UP INFO WAS RECEIVED ON 05/10/2011 VIAL MEDICAL RECORDS. ON (B)(6) 2009, THE PT REPORTED BILATERAL PARESTHESIAS AS PRESENTING IN A STOCKING DISTRIBUTION AND MORE PROMINENT AT NIGHT, INTERMITTENT ACHING AND COLD FEELING IN THE DISTAL LOWER EXTREMITIES. ELECTROMYOGRAM (EMG) STUDIES SHOWED EVIDENCE SUGGESTING AN AXONAL AND DEMYELINATING PERIPHERAL POLYNEUROPATHY INVOLVING SENSORY AND MOTOR FIBERS IN BOTH LOWER EXTREMITIES. ON (B)(6) 2009, THE PT REPORTED INADEQUATE RESPONSE WITH THE USE OF ZONALON CREAM TO TREAT DISTAL LOWER EXTREMITY SENSORY NEUROPATHY. ON (B)(6) 2011, IT WAS NOTED THE PT HAD A HISTORY SIGNIFICANT FOR BEING OVERMEDICATED ON OPIOIDS. ON (B)(6) 2011, THE PT'S COPPER LEVEL WAS 203 MCG/DL (NORMAL 70 TO 155) AND ZINC LEVEL WAS 168 MCG/DL (NORMAL 70 TO 150). THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS AFTER FURTHER ASSESSMENT BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT - SUSPECT MEDICATION| (DATE OF TX: 2000 - 2010)