BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP AND POLIGRIP

    MDR report key: 1962894 · Received January 12, 2011

    Report

    Report Number
    9681138-2011-00010
    Event Type
    Other
    Date Received
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT AND DESCRIBED THE OCCURRENCE OF INJURY 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. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING SUPER POLIGRIP. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED AN UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. MEDICAL RECORDS RECEIVED (B)(4) 2010: ON (B)(6) 2010, COPPER WAS MEASURED AT 5 MCG/DL (NORMAL 70 TO 155) AND ZINC WAS 179 MCG/DL (NORMAL 70 TO 150). FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PATIENT COMPLAINED OF BILATERAL LEG PAIN, BONE PAIN OVER ENTIRE BODY, AND CERTAIN AREAS WERE SORE TO TOUCH. ON (B)(6) 2010, THE PATIENT HAD LEUKOPENIA, ANEMIA, AND SEVERE NEUTROPENIA WITH ABSOLUTE NEUTROPHIL COUNT (ANC) OF 300. ON (B)(6) 2010, IMPRESSION INCLUDED PERIPHERAL VASCULAR DISEASE INVOLVING THE RIGHT LOWER EXTREMITY. ON (B)(6) 2010, THE PATIENT HAD DONE SOME RESEARCH AND WAS AFRAID SHE HAD ZINC POISONING. THE PATIENT REPORTED THAT SHE CONTINUED TO HAVE PROBLEMS WITH WEAKNESS AND NUMBNESS IN HER LEGS AND HAD IMBALANCE. THE PATIENT STATED THAT SHE SAW A COMMERCIAL ON TELEVISION ABOUT POLIGRIP (FORMULATION UNKNOWN) USED IN DENTURES CAUSING ZINC TOXICITY AND HAD SOME OF THE SYMPTOMS MENTIONED, INCLUDING ANEMIA. THE PATIENT REQUESTED BLOOD TESTS. A BONE MARROW FLOW CYTOMETRY ANALYSIS DUE TO ANEMIA AND SEVERE NEUTROPENIA WAS NONSPECIFIC, BUT FINDINGS COULD BE SEEN IN MYELODYSPLASTIC SYNDROME. BONE MARROW ASPIRATE AND BIOPSY SHOWED NO EVIDENCE OF MYELODYSPLASIA. ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS DEFICIENT AND MIGHT BE THE CAUSE OF HER NEUROLOGICAL SYMPTOMS (IMBALANCE, ATAXIA, AN HEMATOLOGIC ABNORMALITIES). THE PATIENT ALSO HAD ELEVATED SERUM ZINC, WHICH COULD BE THE CAUSE OF HER COPPER LEVEL. ORAL COPPER SUPPLEMENTATION WAS RECOMMENDED, BUT TREATMENT RECOMMENDATIONS WERE REFERRED TO HEMATOLOGY/ONCOLOGY. ON (B)(6) 2010, THE PATIENT WAS NOTED TO HAVE A VERY DECREASED COPPER LEVEL OF FIVE AND AN ELEVATED ZINC LEVEL OF 179 (THE UPPER LIMIT BEGAN AT 150 MCG/DL). THE PATIENT HAD BEEN ON POLIGRIP FOR 10 YEARS. THE PATIENT WAS STARTED ON COPPER SUPPLEMENTS 2 MG DAILY AND HAD BEEN OFF OF POLIGRIP FOR A LITTLE OVER A WEEK NOW. THE PATIENT STATED SHE ALREADY FELT BETTER AND HER BLOOD COUNTS HAD IMPROVED SIGNIFICANTLY. THE PATIENT HAD NUMBNESS STARTING AT HER FEET, TWO YEARS AGO IN APPROXIMATELY 2008, AND HAD PROGRESSED UP HER LEGS TO ABOVE HER HANDS TO SOME EXTENT NOW AS WELL. (B)(6) 2010, THE PATIENT COMPLAINED OF LEG PAIN AND WAS DIAGNOSED WITH ANEMIA, NEUTROPENIA, AND NEUROPATHY SECONDARY TO LOW COPPER, HIGH ZINC. THE PATIENT'S COMPLETE BLOOD COUNT (CBC) HAD NOW COMPLETELY NORMALIZED ON ORAL COPPER. IMPRESSION INCLUDED NEUROPATHY AND LOW COPPER LEVEL WITH ELEVATED ZINC SECONDARY TO PROLONGED USE OF POLIGRIP DENTURE CREAM. THE PATIENT CONTINUED ON COPPER REPLACEMENT. ON (B)(6) 2010, IT WAS NOTED THE PATIENT FIRST NOTICED THAT SHE WAS HAVING PROBLEMS WITH NUMBNESS AND TINGLING IN BOTH OF HER FEET LAST YEAR (APPROXIMATELY 2009). THIS EVENTUALLY SPREAD UP TO HER KNEES AND HER HIPS. IN (B)(6) 2009, SHE NOTED A DRAMATIC WORSENING OF HER CONDITION, IN THAT SHE HAD LEG WEAKNESS AND HER BALANCE WAS VERY POOR. SHE ALSO DEVELOPED TINGLING IN THE HANDS. THE PATIENT STILL HAD PERSISTENT SYMPTOMS IN THE LEGS, THOUGH HER HANDS HAD IMPROVED SOME. SHE CONTINUED TO STRUGGLE WITH BALANCE. ASSESSMENT INCLUDED IDIOPATHIC PERIPHERAL NEUROPATHY. ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 93 (NORMAL 70 TO 155 MCG/DL) AND ZINC LEVEL WAS 143 (70 TO 150 MCG/DL). THE PATIENT CONTINUED TO HAVE PROBLEMS WITH WEAKNESS AND NUMBNESS IN HER LEGS AND IMBALANCE. ON (B)(6) 2010, ZINC AND COPPER LEVELS WERE NOW WITHIN NORMAL RANGE. ON (B)(6) 2010, NERVE CONDUCTION STUDIES AND ELECTROMYOGRAM SHOWED THE PRESENCE OF A MODERATE SENSORIMOTOR NEUROPATHY WITH PRIMARILY AXONAL FEATURES. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2011-00010. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other