BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2163611 · Received June 8, 2011

    Report

    Report Number
    9681138-2011-00138
    Event Type
    Other
    Date Received
    June 8, 2011
    Report Date
    June 7, 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 AND DESCRIBED THE OCCURRENCE OF NERVE DAMAGE IN A MALE PT WHO USED POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NERVE DAMAGE. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. F/U INFO WAS RECEIVED ON 20 SEPTEMBER 2010, VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PT WAS SEEN IN A FOLLOW UP FOR CHRONIC IDIOPATHIC PERIPHERAL NEUROPATHY, WHICH BEGAN FOUR YEARS AGO (2005). THE PT COMPLAINED OF MODERATE PAIN ON THE BOTTOM OF BOTH FEET THAT OCCURRED CONSTANTLY, AND HAD AN UNSTEADY GAIT. THE PT HAD A HISTORY OF ALCOHOL ABUSE. HE STOPPED DRINKING FIVE TO SIX MONTH AGO. THE PT'S SYMPTOMS WERE AGGRAVATED BY MOVEMENT AND WERE NOT RELIEVED, BUT ASSOCIATED WITH PARESTHESIAS AND TINGLING. F/U INFO WAS RECEIVED ON 14 FEB, 2011, VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PT'S ZINC LEVEL WAS 61.70 UG/L (NORMAL 500 TO 1000 UG/L) AND COPPER LEVEL WAS 6.67 UG/L (NORMAL 600 TO 1400 UG/L). FOLLOW UP INFO WAS RECEIVED ON 23 MAY 2011, VIA FACT SHEETS SENT BY THE PT AND/OR THE PT'S ATTORNEY. IN 1995, THE PT HAS A TORN CARTILAGE IN THE KNEE DURING MILITARY TRAINING, FOLLOWED BY KNEE REPLACEMENT SURGERY WITH COMPLICATIONS, RESULTING IN DISABILITY. THE PT FIRST USED UPPER AND LOWER DENTURES IN 1993. THE PT USED SUPER POLIGRIP ORIGINAL FROM 1993 UNTIL 2010, ONCE A DAY, ONE FOURTH OF A 2.4 OUNCE TUBE. THE PT EXPERIENCED HYPOCUPREMIA, NEUROPATHY, SEVERE NERVE DETERIORATION, LOSS OF BALANCE/COORDINATION PROBLEMS, SEVERE PAIN AND DISCOMFORT IN EXTREMITIES, BURNING SENSATION IN THE EXTREMITIES, DECREASED ENERGY, AND "PROFOUND AND IRREVERSIBLE NEUROLOGICAL DAMAGE." 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