BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL

    MDR report key: 2093575 · Received April 15, 2011

    Report

    Report Number
    9681138-2011-00089
    Event Type
    Other
    Date Received
    April 15, 2011
    Report Date
    April 13, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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 VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF ZINC TOXICITY IN A MALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL ((B)(4)) DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. IN 2005, THE PT BEGAN USING SUPER POLIGRIP ORIGINAL. THIS WAS DISCONTINUED IN 2007, AND THAT SAME YEAR THE PT BEGAN USING FIXODENT. ON AN UNK DATE, THE PT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE EXTREME LEG WEAKNESS AND DIFFICULTY WALKING WHICH NECESSITATES USE OF A WALKER." USE OF FIXODENT WAS DISCONTINUED ON (B)(6) 2010. ACCORDING TO THE CLAIM, THE EVENTS WERE SEVERE AND PERMANENT. MEDICAL RECORDS RECEIVED (B)(6) 2011: IN 1999, THE PT SUFFERED A STROKE WITH RESULTING HEMIPARESIS. HE WAS SEEN ON SEVERAL OCCASIONS SINCE THAT TIME FOR CHANGING WEAKNESS IN THE LEFT LEG. IN (B)(6) 2010, THE PT HAD ADDITIONAL ONSET OF BILATERAL WEAKNESS AND WAS ONLY ABLE TO AMBULATE WITH ASSISTANCE. THIS HAD A VERY SUDDEN ONSET AND BRAIN MRI ON (B)(6) 2010, SHOWED SIGNIFICANT VERTEBROBASILAR CIRCULATION DISEASE WITH MODERATE TO MODERATE-TO-SEVERE IRREGULARITY AND STENOSIS IN THE RIGHT VERTEBRAL ARTERY. HE WAS STARTED ON PHYSICAL THERAPY WITH IMPROVEMENT NOTED ON (B)(6) 2010. ON (B)(6) 2010, THE PT WAS NOTED TO HAVE USED DENTURE CREAM FOR YEARS AND HIS ZINC LEVEL HAD COME BACK ELEVATED. HE HAD BEEN OFF THE ADHESIVE FOR ABOUT 2 WEEKS AT THAT TIME. ON (B)(6) 2010, IT WAS NOTED THAT THE PT ATTRIBUTED HIS WEAKNESS TO ELEVATED ZINC FROM DENTURE ADHESIVE USE. HIS ZINC LEVEL WAS REDUCING ADEQUATELY WITH RECENT COPPER LEVEL BEING NORMAL. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2010, WHILE HOSPITALIZED FOR DEBILITY FOLLOWING SEPSIS INCLUDING BACTEREMIA AND URINARY TRACT INFECTION, THE PT WAS EVALUATED BY NEUROSURGERY. A MAGNETIC RESONANCE IMAGING (MRI) SCAN SHOWED A TETHER CORD SYNDROME, WHICH WAS A SERENDIPITOUS FIND. ON (B)(6) 2010, THE PT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LOWER EXTREMITY PARESTHESIAS. HE WAS DISCHARGED THE PREVIOUS DAY, BUT STILL COMPLAINED OF WORSENING WEAKNESS IN HIS LOWER EXTREMITIES AND SUFFERED A FALL THIS MORNING. THE PT WAS DISCHARGED WITH A DIAGNOSIS OF WEAKNESS. ON (B)(6) 2010, ELECTROMYOGRAM (EMG)/NERVE CONDUCTION STUDY (NCS) SHOWED AN EARLY AXONAL NEUROPATHY MIGHT BE PRESENT. ON (B)(6) 2010, IMPRESSION INCLUDED LOWER EXTREMITY WEAKNESS, POSSIBLE MYELOPATHY. ON (B)(6) 2010, COPPER LEVEL WAS NORMAL AND ZINC LEVEL WAS 1.52 (NORMAL 0.66 TO 1.10 MCG/ML). ON (B)(6) 2010, ASSESSMENT INCLUDED NEUROPATHY WITH WEAKNESS. ON (B)(6) 2010, ZINC LEVEL WAS NORMAL AT 1.29

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT