BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1821652 · Received August 24, 2010

    Report

    Report Number
    9681138-2010-00303
    Event Type
    Other
    Date Received
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA LITIGATION PROCEEDINGS, AND DESCRIBED THE OCCURRENCE OF ZINC POISONING IN A MALE PT WHO USED POLIGRIP DENTURE ADHESIVE CREAM (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ACCORDING TO THE NOTIFICATION FROM THE LAWYER, THE PT BEGAN USING POLIGRIP ON AN UNK DATE. THE PT ALLEGED "PERSONAL INJURIES, INCLUDING HEAVY METAL (ZINC) POISONING AND NEUROLOGICAL DAMAGES DUE TO HIS INGESTION OF POLIGRIP." AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT(S) WAS UNK. FOLLOW-UP WAS RECEIVED VIA MEDICAL RECORDS ON (B)(4) 2010. ON (B)(6) 2010: URINE ZINC AND COPPER WERE FOUND TO BE ELEVATED AT 4700 AND 2400, RESPECTIVELY. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS (MULTIPLE HANDWRITTEN AND ILLEGIBLE NOTES). ON (B)(6) 2010, THE PT'S ZINC LEVEL WAS 170 (NORMAL 60 TO 130 MCG/DL). ON (B)(6) 2010, IT WAS NOTED THE PT HAD AN INCREASED ZINC LEVEL WITH LOW COPPER LEVEL, CONSISTENT WITH ZINC EXCESS POSSIBLY FROM POLIGRIP. ON (B)(6) 2010, THE PT WAS TREATED WITH SUPPLEMENTAL COPPER, POSSIBLY INTRAVENOUSLY. ON (B)(6) 2010, THE PT'S PROBLEMS INCLUDED ZINC TOXICITY AND COPPER DEFICIENCY WITH WEAKNESS. THE PT'S ZINC LEVEL WAS 77 (NORMAL 60 TO 130 MCG/DL) AND COPPER LEVEL WAS 109 (NORMAL 70 TO 175 MCG/DL). FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2010, THE PT WAS SEEN BY A NEUROLOGIST. THE PT HAD WORN DENTURES FOR APPROXIMATELY 17 YEARS. THE PT WAS USING "QUITE A BIT" OF POLIGRIP AT THAT TIME. APPROXIMATELY A YEAR OR SO AGO (IN 2009), THE PT DEVELOPED NUMBNESS AND TINGLING IN ALL THE FINGERS OF BOTH HANDS. THIS PROGRESSED TO THE FEET IN (B)(6) 2009. IT HAS SINCE ASCENDED TO ABOVE THE KNEES. THE PT WAS TREATED WITH NEURONTIN WITH NO IMPROVEMENT. THE PT HAD BEEN TRIED ON MULTIPLE ANTIDEPRESSANTS WITH NO IMPROVEMENT. URINE AND SERUM ZINC LEVELS WERE SIGNIFICANTLY ELEVATED, AND COPPER LEVEL WAS LOW. SINCE STOPPING THE POLIGRIP, THE PT'S ZINC AND COPPER LEVELS HAD NORMALIZED. THE PT WAS DIAGNOSED WITH PERIPHERAL NEUROPATHY THAT WAS POSSIBLY DUE TO HIS ZINC TOXICITY. NEURONTIN WAS INCREASED. PHYSICAL THERAPY WAS ARRANGED. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other