BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT

    MDR report key: 2226733 · Received August 22, 2011

    Report

    Report Number
    1020379-2011-00013
    Event Type
    Other
    Date Received
    August 22, 2011
    Date of Event
    January 1, 2005
    Report Date
    September 7, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2011-00211. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. THE MFR'S REPORT NUMBER ALSO FOR THIS CASE IS 1020379-2011-00013. POLIDENT WAS 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 ZINC TOXICITY IN A FEMALE PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE CREAM. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. IN 2005, THE PT USED SUPER POLIGRIP AT UNK DOSING. ON AN UNK DATE, THE PT EXPERIENCED ZINC TOXICITY, PAIN, WEAKNESS IN EXTREMITY, NUMBNESS OF EXTREMITIES, TINGLING OF EXTREMITY, CENTRAL NERVOUS SYSTEM DISORDER, SPINAL DISORDER, BLOOD PRESSURE ABNORMAL, AND SEXUAL DYSFUNCTION. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. ACCORDING TO THE LEGAL COMPLAINT, THE PT EXPERIENCED "ZINC TOXICITY, PAIN, WEAKNESS, NUMBNESS AND TINGLING OF THE SPINE AND CENTRAL NERVOUS SYSTEM; ABNORMAL BLOOD PRESSURE AND SEXUAL DYSFUNCTION." F/U INFO WAS RECEIVED ON AUGUST 15, 2011 VIA MEDICAL RECORDS. ON (B)(6) 2010, ELECTROMYOGRAPHY/NERVE CONDUCTION STUDY SHOWED NO EVIDENCE OF PERIPHERAL NEUROPATHY IN THE LOWER EXTREMITIES. ELECTROMYOGRAPHY OF THE PARASPINAL LUMBAR MUSCLES REVEALED ACTIVE DENERVATION CONSISTENT WITH DORSAL RAMI L4/L5/S1 RADICULOPATHY ON THE RIGHT. ON (B)(6) 2011, THE PT HAD A NEUROLOGY CONSULT DUE TO COMPLAINTS OF MEMORY LOSS, BACK PAIN, PARESTHESIAS IN THE LOWER EXTREMITIES, POOR BALANCE, A FEELING OF THE ROOM SPINNING, SEIZURES, AND DIFFICULTY WITH WEAKNESS AND COORDINATION TO THE LOWER EXTREMITIES. IMPRESSION INCLUDED POSSIBLE CERVICAL MYELOPATHY AND POSSIBLE UNDERLYING NEUROPATHY. ON (B)(6) 2010, ASSESSMENT INCLUDED PARESTHESIA. THE PT WANTED TO BE CHECKED FOR HEAVY METALS BECAUSE SHE WAS USING A DENTURE CREAM ASSOCIATED WITH TOXICITY. ON (B)(6) 2010, THE PT'S ZINC LEVEL WAS 262 MCG/DL (NORMAL 60 TO 130) AND THE COPPER LEVEL WAS 94 MCG/DL (NORMAL 70 TO 175). ON (B)(6) 2010, THE PT HAD ELEVATED ZINC LEVELS AND WAS USING POLIDENT. ON (B)(6) 2011, THE PT REPORTED HAVING USED FIXODENT DENTURE CREAM, BELIEVING THERE WAS NO ZINC IN THE PRODUCT. SHE STATED THE ZINC CAUSED NEUROPATHIC PAIN. THE PT REPORTED HAVING ARM PAIN, WEAKNESS, AND NUMBNESS FOR TWO WEEKS. THE PT WENT BACK TO USING DENTURE ADHESIVE WITH ZINC IN IT AND SINCE THEN WAS HAVING MORE PAIN AND NUMBNESS. ASSESSMENT INCLUDED MILD NECK PAIN, POSSIBLE RADICULOPATHY VERSUS NEUROPATHY. THIS CASE HAS BEEN UPGRADED TO MEDICALLY SERIOUS BY GSK. F/U INFO WAS RECEIVED ON AUGUST 29, 2011 VIA FACT SHEETS COMPLETED BY THE PT AND/OR THE PT'S ATTORNEY. FIXODENT (ALL TYPES OF FORMULATIONS OF THE PRODUCT) WAS USED FROM 2004/2005 UNTIL (B)(6) 2011, USED THREE TO FOUR TIMES A DAY, APPROX TWO 2.4 OUNCE TUBES A WEEK. SUPER POLIGRIP (ALL TYPES OF FORMULATIONS OF THE PRODUCT) WAS USED FROM 2004/2005 UNTIL THE TIME OF THIS REPORT, USED THREE TO FOUR TIMES A DAY, APPROX 2.4 OUNCE TUBES A WEEK. THERE WAS NO MENTION OF POLIDENT. THE PT EXPERIENCED MEMORY LOSS, SEIZURES, AND SEXUAL DYSFUNCTION IN 2005; AND BACK PAIN AND NUMBNESS AND TINGLING IN HANDS AND FEET IN 2008. THE PT ALSO EXPERIENCED HYPOCUPREMIA, COPPER DEFICIENCY AND MYELOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DOUBLE SALT DENTURE CLEANSER MFC50075 EFT GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other