BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2573852 · Received May 9, 2012

    Report

    Report Number
    9681138-2012-00054
    Event Type
    Other
    Date Received
    May 9, 2012
    Report Date
    May 8, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HIGH IN A (B)(6) MALE PT WHO USED POLIGRIP OVER A PERIOD OF 30 PLUS YEARS AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PT USED POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIGRIP, THE PT EXPERIENCED ZINC HIGH AND PHYSICAL INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE PT WAS UNKNOWN. INFO FROM AN ADDITIONAL LEGAL CLAIM RECEIVED 02/13/2012: THE PT USED SUPER POLIGRIP ORIGINAL FROM 1979 TO THE PRESENT AND FIXODENT FROM 1979 TO THE PRESENT. ACCORDING TO THE CLAIM, THE PT EXPERIENCED PROFOUND AND PERMANENT NEUROLOGICAL INJURIES. FOLLOW UP INFO WAS RECEIVED ON 04/30/2012 VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PT WAS DESCRIBED AS HAVING A RELATIVELY SUDDEN ONSET SEVERAL MONTHS AGO OF WEAKNESS IN THE EXTREMITIES, RIGHT GREATER THAN LEFT. ELECTROMYOGRAM AND NERVE CONDUCTION VELOCITY STUDIES SHOWED POLYNEUROPATHY, PROBABLY AT LEAST IN PART AXONAL IN NATURE, RELATED TO THE DIABETES. THERE ALSO APPEARED TO BE A SUPERIMPOSED, EITHER ANTERIOR HORN CELL OR MOTOR NEUROPATHY PROCESS, PERHAPS EVEN A MYOSITIS. ON (B)(6) 2010, THE PT HAD A HISTORY OF DIABETIC NEUROPATHY AND MYOPATHY BY MUSCLE BIOPSY WITHOUT CLEAR-CUT INFO AND WAS DISABLED DUE TO THIS. HE HAD BEEN UNRESPONSIVE TO TREATMENT. ON (B)(6) 2011, THE PT WAS ON DISABILITY. ON (B)(6) 2011, THE PT HAD A HISTORY OF POLIGRIP AND EFFERDENT USE. ON (B)(6) 2011, THE PT HAD A NEUROMYOPATHY DOCUMENTED BY ELECTROMYOGRAM (EMG), NERVE CONDUCTION VELOCITY (NCV) STUDIES, AND MUSCLE BIOPSY. THE PT WAS STARTED ON PREDNISONE AT 40 MG. THE PT IMPROVED AND FELT LIKE HE COULD GET UP OUT OF A CHAIR WITHOUT DISCOMFORT, BUT ARMS WERE A LITTLE WEAKER. EMG AND NCV STUDIES SHOWED POLYNEUROPATHY, PRIMARILY AXONAL IN NATURE, MOTOR GREATER THAN SENSORY. THERE WAS ALSO MYPATHIC FEATURES OF EMG AND DOCUMENTED MYPATHIC FEATURES ON MUSCLE BIOPSY WITHOUT CLEAR EVIDENCE OF VASCULITIS OR INFLAMMATION. ON (B)(6) 2011, THE PT HAD NORMAL SERUM COPPER AND ZINC LEVELS. ON (B)(6) 2011, THE PT HAD ELEVATED URINE ZINC LEVELS OF 3584 MCG/24 HOURS (NORMAL 150 TO 1200). THIS CASE HAS BEEN 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 59 YR Disability