BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/POLIDENT

    MDR report key: 1971867 · Received January 17, 2011

    Report

    Report Number
    9681138-2011-00015
    Event Type
    Other
    Date Received
    January 17, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 AND DESCRIBED THE OCCURRENCE OF NEUROLOGICAL INJURIES IN A FEMALE PT WHO USED POLIGRIP (FORMULATION UNK) AS DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP AT UNK DOSING. AS AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PT COMPLAINED OF CHRONIC PAIN IN BACK/ LEGS/ NECK/ AND ARMS AND BLADDER PROBLEMS (FREQUENCY AND URGENCY FOR THE PAST COUPLE OF YEARS). THE PT WAS BEING SEEN BY PAIN MANAGEMENT FOR CHRONIC PAIN. ON (B)(6) 2010, THE PT COMPLAINED OF HER FINGERS BEING NUMB. THE PT COMPLAINED OF PAIN IN HER NECK THAT WENT DOWN HER ARMS, WHEN SHE TURNED HER HEAD. SHE ALSO HAD NUMBNESS AND TINGLING IN HER FINGERS THAT WAS WORSE, WHEN SHE TURNED HER HEAD. ON (B)(6) 2010, THE PT WAS EVALUATED BY NEUROSURGERY. THE PT HAD A HISTORY OF PAIN INVOLVING HER NECK REGION WITH RADIATION NONSPECIFICALLY (NONRADICULAR) INTO HER BILATERAL UPPER EXTREMITY. SHE ALSO DESCRIBED A NONSPECIFIC (NONRADICULAR) PATTERN OF NUMBNESS INVOLVING THE TIPS OF HER FINGERS. THE PT HAD CHRONIC SYMPTOMS OF NECK PAIN DATING BACK OVER A YEAR, BUT THEY HAD BEEN WORSE OVER THE LAST FOUR WEEKS WITH THE ONSET NOTED TO BE GRADUAL AND INSIDIOUS WITH THE PAIN PROGRESSIVE. THE PT WAS ON DISABILITY SINCE 1992 FOR LOW BACK PAIN, NECK PAIN, AND DEPRESSION. THE PT HAD POSITIVE SIGNS OF CARPAL TUNNEL SYNDROME PRESENT BILATERALLY. HER CLINICAL DIAGNOSIS WAS PROBABLE CERVICAL SPONDYLOSIS RELATED TO DEGENERATIVE CHANGES, PRODUCING NECK PAIN, COUPLED WITH BILATERAL CARPAL TUNNEL SYNDROME. ON (B)(6) 2010, THE PT WAS STAGGERING AND COMPLAINED THAT HER FEET WERE NUMB. SHE USED POLIDENT (FORMULATION UNK), WHICH SHE HEARD HAD ZINC, WHICH HAD BEEN CAUSING HER TO STAGGER. SHE WANTED HER ZINC LEVEL CHECKED. ON (B)(6) 2010, THE PT WAS STILL STAGGERING WHEN SHE WALKED. ON (B)(6) 2010, ALL STUDIES WERE NORMAL, INCLUDING AN ELECTROMYOGRAM. THERE WERE NO SIGNAL CHANGES WITHIN THE SPINAL CORD, EITHER AT THE LEVEL OF THE SURGERY OR ABOVE OR BELOW IT. THE PHYSICIAN DID NOT SEE ANYTHING FROM A NEUROSURGICAL STANDPOINT THAT WOULD REQUIRE INTERVENTION FOR MANAGEMENT OF THIS PROBLEM. A NEUROLOGY CONSULTATION WAS RECOMMENDED. ON (B)(6) 2010, THE PT REQUESTED THAT HER COPPER LEVEL BE CHECKED. THE PT CONTINUED TO HAVE GAIT ABNORMALITIES. ON (B)(6) 2010, THE PT HAD ELEVATED ZINC AND LOW COPPER LEVELS. COPPER LEVEL WAS 13 (NORMAL 70 TO 175 MCG/DL) ON (B)(6) 2010. ON (B)(6) 2010, THE PT WAS EVALUATED BY NEUROLOGY. THE PT SAW A LAWYER'S TELEVISION ADVERTISEMENT ABOUT HIGH ZINC CONTENT DENTURE CREAM THAT COULD CAUSE COPPER DEFICIENCY AND SUBSEQUENT BALANCE PROBLEMS. THE PT STOPPED USING THE "HIGH ZINC LEVEL" CREAM. ASSESSMENT INCLUDED ATAXIA WITH NO SIGNIFICANT SIGNS OF NEUROPATHY AND POSSIBLE MYELOPATHY DUE TO THE MARKEDLY LOW LEVEL OF SERUM COPPER, AS A RESULT OF TOO MUCH ZINC, WHICH COULD HAVE CAUSED DECREASED ABSORPTION OF COPPER IN THE GASTROINTESTINAL TRACT. THE ZINC WAS MOST LIKELY FROM THE HIGH ZINC CONTENT DENTURE CREAM WHICH THE PT RECENTLY STOPPED. ORAL COPPER SUPPLEMENTATION WAS STARTED. ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 96 (NORMAL 70 TO 175 MCG/DL) AND CERULOPLASMIN LEVEL WAS 22 (NORMAL 18 TO 53 MG/DL). ON (B)(6) 2010, THE PT WAS EVALUATED FOR AN ELECTRIC WHEELCHAIR. THE PT HAD SEVERE IMBALANCE, PROBLEMS COMPLETING ACTIVITIES OF DAILY LIVING, WAS AT A HEIGHTENED RISK FOR FALLS AND HAD FREQUENT FALLS, DIZZINESS, WEAKNESS, SPASTICITY, AND SHORTNESS OF BREATH. THE PT HAD KNOWN ARTHRITIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND NEUROPATHY. THE PHYSICIAN REPORTED IT WAS LIKELY THE PATIENT'S CONDITION WOULD GET WORSE OVER TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other