BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL

    MDR report key: 2111178 · Received May 26, 2011

    Report

    Report Number
    9681138-2011-00129
    Event Type
    Other
    Date Received
    May 26, 2011
    Report Date
    May 24, 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. THE MANUFACTURER'S REPORT NUMBER ALSO FOR THIS CASE IS 1020379-2011-00007. POLIDENT WAS 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 PATIENT WHO USED SUPER POLIGRIP (FORMULATION UNKNOWN) 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 ((B)(4)) AND FIXODENT. IN 1992, THE PATIENT USED SUPER POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING SUPER POLIGRIP, THE PATIENT EXPERIENCED ZINC TOXICITY, NERVE DAMAGE, LOSS OF BALANCE, ABDOMINAL CRAMP, DIZZINESS, TINGLING OF EXTREMITIES, NUMBNESS OF EXTREMITIES, BURNING OF EXTREMITIES, PAIN IN EXTREMITIES, WEAKNESS IN EXTREMITIES, LOSS OF CONTROL OF EXTREMITIES, MUSCLE PAIN, AND JOINT PAIN. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED IN 1998 AND THEN RESUMED IN (B)(6) 2010 TO THE TIME OF THIS REPORT. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE LOSS BALANCE, ABDOMINAL CRAMPS, DIZZINESS, TINGLING, NUMBNESS, BURNING, PAIN, WEAKNESS AND LOSS OF CONTROL IN HER FEET, LEGS, HANDS AND ARMS AND MUSCLE AND JOINT PAIN." THE PATIENT "SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." IT WAS FURTHER REPORTED THE PATIENT'S "INJURIES AND DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE." FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS (PARTS ILLEGIBLE DUE TO HANDWRITTEN NOTES). ON (B)(6) 1999, THE PATIENT COMPLAINED OF RIGHT SHOULDER AND NECK PAIN, WHICH HAD BEEN INTERMITTENT OVER THE PAST TWO YEARS (SINCE APPROXIMATELY 1997). THE PATIENT WAS RECEIVING WORKMAN'S COMPENSATION DUE TO WORK-RELATED CARPEL TUNNEL SYNDROME. AN ELECTROMYOGRAM (EMG) COMPLETED IN (B)(6) 1998, SHOWED A NORMAL CERVICAL SPINAL STUDY. ON (B)(6) 2010, THE PATIENT WAS EVALUATED FOR MULTIPLE NEUROLOGICAL COMPLAINTS. THE PATIENT COMPLAINED OF TINGLING AND NUMBING SENSATION OF HER ARMS AND LEGS FOR ABOUT 12 YEARS (SINCE APPROXIMATELY 1998). THE PATIENT UNDERWENT CARPAL TUNNEL RELEASE SURGERIES IN 1998 AND ONLY NOTICED SLIGHT IMPROVEMENT OF HER ARM SYMPTOMS AFTER THE SURGERY. SHE WAS SEEN BY MULTIPLE PHYSICIANS IN THE PAST FOR NUMEROUS COMPLAINTS, INCLUDING JOINT PAIN/TINGLING/BURNING SENSATION IN DIFFERENT PARTS OF THE BODY, AS WELL AS WEAKNESS. THE PATIENT WAS DIAGNOSED WITH BURSITIS, NEUROPATHY, AND FIBROMYALGIA IN THE PAST. THE PATIENT WORE AN UPPER DENTURE IN 1992 AND A LOWER ONE AROUND 2002. THE PATIENT HAD BEEN USING A DENTURE CREAM WHICH WAS THOUGHT TO HAVE HIGH ZINC CONTENTS. SHE RESEARCHED ON THE INTERNET AND FOUND OUT LOTS OF PEOPLE USED THESE CREAMS AND DEVELOPED SYMPTOMS OF NEUROPATHY. THE PATIENT HAD NEVER HAD PRIOR STUDIES PERFORMED IN THE PAST FOR HER LEGS. THE PATIENT WAS ALSO DIAGNOSED WITH B12 DEFICIENCY PREVIOUSLY. ON (B)(6) 2010, AN ELECTROMYOGRAM (EMG) NERVE CONDUCTION STUDY SHOWED MODERATE RIGHT CARPAL TUNNEL SYNDROME AND MILD LEFT CARPAL TUNNEL SYNDROME. THERE WAS NO EVIDENCE FOR BILATERAL LOWER EXTREMITY LARGE FIBER NEUROPATHY, HOWEVER, NORMAL NERVE CONDUCTION STUDY COULD NOT RULE OUT THE CLINICAL DIAGNOSIS OF SMALL FIBER NEUROPATHY. ON (B)(6) 2010, IT WAS NOTED THE USED POLIDENT AND FIXODENT SINCE 1992 AND HAD AN ELEVATED ZINC LEVEL. THE PATIENT REQUESTED ZINC AND COPPER LEVELS TO BE TESTED. ON (B)(6) 2010, THE PATIENT HAD A NORMAL VITAMIN B12 LEVEL AND 24 HOUR URINE ZINC LEVEL WAS 2649 MCG/24 HOURS (NORMAL 100 TO 1200). ON (B)(6) 2010, IT WAS NOTED THE PATIENT WAS USING DENTURE CREAM WITH ZINC, BUT STOPPED. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT (1992 - (B)(6)2010) - SUSPECT MEDICATION