BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2640459 · Received June 27, 2012

    Report

    Report Number
    9681138-2012-00067
    Event Type
    Other
    Date Received
    June 27, 2012
    Date of Event
    January 1, 2004
    Report Date
    June 26, 2012
    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

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00067. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE.

    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 SUPER POLIGRIP ORIGINAL AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. IN 1990, THE PT USED SUPER POLIGRIP ORIGINAL AT AN UNK TIME AFTER USING SUPER POLIGRIP ORIGINAL, THE PT EXPERIENCED NERVE DAMAGE. TREATMENT WITH SUPER POLIGRIP ORIGINAL WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. NO SPECIFIC INJURIES WERE IDENTIFIED AT THIS TIME. ACCORDING TO THE LEGAL COMPLAINT, THE PT EXPERIENCED NEUROLOGICAL DISORDERS. THE PT "SUFFERED, AND CONTINUES TO SUFFER FROM SEVERE MENTAL AND EMOTIONAL INJURIES, INCLUDING BUT NOT LIMITED TO, SEVERE EMOTIONAL DISTRESS, DEPRESSION, ANXIETY, WORRY AND ANGUISH." 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 10/10/2011 VIA FACT SHEETS COMPLETED BY THE PT AND/OR THE PT'S ATTORNEY. POLIGRIP (MARKETED AS SUPER POLIGRIP IN THE U.S.) AND FIXODENT COMPLETE WERE USED IN OR AROUND EARLY 1990'S TO THE PRESENT, USED ONE TO THREE TIMES DAILY, ON-HALF OF A 2.4 OUNCE TUBE A WEEK AND/OR ONE 1.4 HOUSE TUBE A WEEK. THE PT EXPERIENCED HYPERGLYCEMIA/ZINC OVERLOAD, TINGLING AND NUMBNESS IN EXTREMITIES, REDUCED DEXTERITY, AND PAIN. SYMPTOMS BEGAN IN OR AROUND 2004. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PT HAD A HISTORY OF COCAINE ABUSE, ALCOHOLISM, AND CHRONIC USE OF XANAX AND ULTRAM. ON (B)(6) 2011, THE PT'S ZINC LEVEL WAS 150 MCG/DL (NORMAL 60 TO 130). FOLLOW UP INFO WAS RECEIVED ON 06/19/2012 VIA MEDICAL RECORDS. ON (B)(6) 2011, THE PT WAS SEEN BY NEUROLOGY AND HAD DEVELOPED NUMBNESS AND TINGLING IN ALL FUR EXTREMITIES IN THE LAST SIX YEARS (ONSET APPROX 2005). THE PT REPORTED BEING EXPOSED TO A GREAT DEAL OF ZINC USING FIXODENT AND SIMILAR PRODUCTS, AND HE HAD BEEN EDENTULOUS FOR 20 YEARS (SINCE 1991) AND HAD DIFFICULTY GETTING HIS DENTURES TO FIT. THE PT HAD A HISTORY OF PANCREATITIS AND (B)(6). THE PT HAD BEEN ALCOHOL FREE FOR OVER 15 YEARS AND HIS LAST DRINK WAS ON (B)(6) 1999. IMPRESSION INCLUDED IDIOPATHIC PAINLESS, PROBABLY SMALL FIBER SENSORY NEUROPATHY. 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 53 YR Other