BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1884991 · Received October 21, 2010

    Report

    Report Number
    9681138-2010-00357
    Event Type
    Other
    Date Received
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 AND DESCRIBED THE OCCURRENCE OF COPPER DEFICIENCY IN A MALE PATIENT WHO USED 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 USED POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER USING POLIGRIP, THE PATIENT EXPERIENCED COPPER DEFICIENCY, ZINC POISONING, AND NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACCORDING TO A LEGAL CLAIM, THERE WERE 26 PATIENTS WHO REPORTED BEING REGULAR USERS OF ZINC-CONTAINING POLIGRIP OR A COMBINATION OF ZINC-CONTAINING POLIGRIP AND FIXODENT. ALL OF THE PATIENTS EXPERIENCED "NEUROLOGICAL MANIFESTATIONS OF ZINC-INDUCED COPPER DEFICIENCY." THE ATTORNEYS BELIEVED THAT THEIR "CLIENTS' USE OF POLIGRIP WAS THE SUBSTANTIAL AND PROVABLE CAUSE OF THEIR INJURIES." FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2005, THE PATIENT WAS SEEN FOR EVALUATION OF CHRONIC RIGHT BUTTOCK/LEG PAIN AND OCCASIONAL BACK PAIN, WHICH BEGAN TWO YEARS PREVIOUSLY (2003), AFTER NO PARTICULAR INITIATING EVENT AND HAD CONTINUED OFF AND ON SINCE. MAGNETIC RESONANCE IMAGING (MRI) OF THE LUMBAR SPINE ON (B)(6) 2005 SHOWED A SMALL DISC HERNIATION PRESENT PARACENTRALLY AT L5/S1, IMPINGING ON THE S1 NERVE ROOT. NONSURGICAL MANAGEMENT WAS SUGGESTED INITIALLY. ON (B)(6) 2006, THE PATIENT WAS SEEN FOR ACUTE ONSET OF PROGRESSIVE, SEVERE NEUROPATHY. THE PATIENT COMPLAINED OF A RAPIDLY, PROGRESSIVE ONSET OF TINGLING AND NUMBNESS IN HIS DISTAL LOWER AND UPPER EXTREMITIES, WHICH WAS ALL NOTICED IN (B)(6) 2005. THE PATIENT WAS TREATED WITH A B12 INJECTION APPROXIMATELY ONE WEEK AGO AND WAS REFERRED FOR WORKUP OF ANEMIA AND CHRONIC NEUTROPENIA. THE PATIENT STATED THAT HIS SYMPTOMS BEGAN IN HIS TOES AND FEET AND WITHIN WEEKS ASCENDED UP TO HIS MID THIGHS IN A SYMMETRIC DISTRIBUTION AND BEGAN TO INVOLVE HIS HANDS AND UPPER EXTREMITIES. HE ALSO COMPLAINED OF SOME PAIN IN HIS JOINTS. ON (B)(6) 2006, ELECTROMYOGRAPHY (EMG) AND NERVE CONDUCTION VELOCITY TESTS SHOWED EVIDENCE FOR A MILD RIGHT ULNAR MONONEUROPATHY ACROSS THE ELBOW AND FOR A VERY MILD LENGTH-DEPENDENT AXONAL POLYNEUROPATHY. A SMALL FIBER NEUROPATHY COULD NOT BE RULED OUT. ON (B)(6) 2006, HIS SYMPTOMS REMAINED CONSTANT AND HAD NOT WORSENED. THE PATIENT CONTINUED EMPIRIC TREATMENT WITH VITAMIN B12 INJECTIONS. THE PATIENT HAD A LOW VITAMIN B12 LEVEL OF 182 BACK IN (B)(6) 2005. THE PATIENT HAD NO NEW CLINICAL COMPLAINTS. ON (B)(6) 2006, MRI OF THE CERVICAL SPINE SHOWED MILD DEGENERATIVE CHANGES RESULTING IN MILD BILATERAL FORAMINAL NARROWING AT C3/4 DUE TO OSTEOPHYTIC ENCROACHMENT BUT NO FORAMINAL NARROWING AT C4/5, MODERATE LEFT FORAMINAL NARROWING AT C5/6 DUE TO OSTEOPHYTIC ENCROACHMENT; MIDLINE POSTERIOR DISC HERNIATION AT C5/6 MILDLY DEFORMING THE CORD AND CREATING VERY MILD SPINAL STENOSIS; SCLEROTIC OSTEOPHYTE EXTENDING OFF THE RIGHT T3/4 FACETS, MILDLY DEFORMING THE POSTERIOR LATERAL ASPECT OF THE CORD; AND INCREASED SIGNAL WITHIN THE MID-PORTION OF THE CORD EXTENDING FROM C2 THROUGH C7. IMAGING CHARACTERISTICS WERE SUGGESTIVE OF A POSSIBLE DEMYELINATING CONDITION. ON (B)(6) 2006, IT WAS NOTED THE PATIENT HAD CERVICAL STENOSIS SECONDARY TO DISC PROTRUSION PRESENT AT C5/6 WITH SLIGHT IMPINGEMENT OF THE CORD AT THAT LEVEL WITH OTHER LEVELS BEING QUITE UNREMARKABLE. THE PATIENT HAD SOME SIGNIFICANT CERVICAL OR RADICULAR PAIN, BUT NO CHANGE IN BOWEL OR BLADDER FUNCTION. THE PATIENT NOTED SOME IMPROVEMENT OF HIS PAIN WITH NEURONTIN. THE IMPRESSION WAS NONSPECIFIC CORD COMPRESSION AT C5/6 WITH NO EVIDENCE OF MYELOMALACIA CHANGES. THE PHYSICIAN DID NOT BELIEVE THE PATIENT'S SYMPTOMS WERE A RESULT OF THE CERVICAL DISC PROTRUSION PRESENT AT C5/6 AND AGREED THAT THIS MOST LIKELY REPRESENTED A NEUROPATHY OF SOME SORT. NO FURTHER NEUROSURGICAL FOLLOW UP WAS NECESSARY AT THAT TIME. ON (B)(6) 2006, A NUMBER OF INITIAL STUDIES HAD NOT FOUND A CAUSE FOR THE PATIENT'S RAPIDLY PROGRESSIVELY SENSORY POLYNEUROPATHY OR PERSISTENT PANCYTOPENIA. THE PATIENT'S VITAMIN B12 LEVEL WAS NOW IN NORMAL RANGE. HE CONTINUED TO HAVE SOME PROGRESSION OF HIS NEUROPATHIC PAIN REGARDING TINGLING AND PAINFUL PARESTHESIAS, WHICH INVOLVED HIS LOWER EXTREMITIES, NOW UP TO HIS GROIN AND HIS UPPER EXTREMITIES, NOW TO HIS MID FOREARMS. THE PATIENT HAD SOME TROUBLE MANIPULATING OBJECTS IN HIS HANDS AT TIMES AND HAD A MILDLY UNSTEADY GAIT. THE PATIENT HAD BEGUN TO NOTICE SYMPTOMS CONSISTENT WITH RESTLESS LEG SYNDROME IN THE EVENING. ON (B)(6) 2006, THE PATIENT'S ETIOLOGY WAS STILL UNCLEAR. ON (B)(6) 2006, IMPRESSION INCLUDED PARESTHESIAS, ANEMIA, AND SLEEP DISORDER. THE PATIENT REPORTED SLEEPING SIX OR SEVEN HOURS, BUT NOT FEELING RESTED IN THE MORNING. ON (B)(6) 2006, IT WAS NOTED THAT THERE WAS CONCERN THAT THE PATIENT CONTINUED TO HAVE PROGRESSIVE PANCYTOPENIA OF UNKNOWN CAUSE, EVEN AFTER A NORMAL BONE MARROW BIOPSY. ON (B)(6) 2006, THE PATIENT'S COPPER WAS LESS THAN 10 (NORMAL 70 TO 155). SINCE (B)(6) 2006, THE PATIENT WAS BEING SEEN FOR PANCYTOPENIA AND TREATED WITH ARANESP FOR ANEMIA. ON (B)(6) 2006, IT WAS NOTED THE PATIENT STARTED COPPER GLUCONATE ON (B)(6) 2006 FOR COPPER DEFICIENCY. THE PATIENT'S COPPER LEVEL WAS NOW 43. ON (B)(6) 2006, THE PATIENT HAD BEEN DIAGNOSED WITH COPPER DEFICIENCY. HE STARTED COPPER REPLACEMENT EIGHT WEEKS AGO AND NOTED A DRAMATIC IMPROVEMENT IN HIS SYMPTOMS. THE PATIENT'S CHRONIC PANCYTOPENIA HAD RESOLVED. HE REQUIRED NO FURTHER BLOOD TRANSFUSIONS. THE PATIENT'S ENERGY LEVEL HAD SIGNIFICANTLY IMPROVED AND HE WAS FEELING BETTER THAN HE HAD IN SOME TIME, BUT HIS OVERALL SYMPTOMS WERE UNCHANGED. ON (B)(6) 2007, THE PATIENT'S COPPER LEVEL WAS 95 (NORMAL 70 TO 155 UG/DL). ON (B)(6) 2007, TREATMENT INCLUDED GABAPENTIN NIGHTLY. THE PATIENT WAS CLINICALLY UNCHANGED AND HAD DECREASED SENSATION IN THE DISTAL LOWER EXTREMITIES AND A MILDLY WIDE-BASED GAIT. ON (B)(6) 2007, THE PATIENT WAS SEEN IN FOLLOW UP OF PERIPHERAL NEUROPATHY WITH CONTINUED TINGLING/NUMBNESS IN FINGERS/LEGS, WANTING TO TRY LYRICA. LYRICA WAS PRESCRIBED. ON (B)(6) 2007, IT WAS NOTED THE PATIENT'S COPPER LEVEL WAS 87 AND HEMOGLOBIN AND HEMATOCRIT WERE 13.9/41.2 ON (B)(6) 2007. ON (B)(6) 2008, THE PATIENT WAS SEEN IN AN INITIAL EVALUATION OF HAND AND FOOT BURNING, NUMBNESS, AND TINGLING. THE PATIENT'S SYMPTOMS BEGAN IN 2005 AND HE HAD A FULL WORK UP. ELECTROMYOGRAPH (EMG) AND NERVE CONDUCTION STUDIES AND A DIAGNOSIS OF ANEMIA, LED TO HIS DIAGNOSIS OF COPPER DEFICIENCY. IT WAS ASSUMED THAT HE HAD A COPPER NEUROPATHY. HIS PAIN WAS CONSTANT, RANGING FROM 3 TO 10 OF 10; INCREASED BY DAILY ACTIVITIES; AND RELIEVED BY SLEEP. HE REPORTED SOME PROBLEMS WITH JOINT PAIN AND STIFFNESS. TREATMENT INCLUDED NEURONTIN AND CYMBALTA. HE WAS ON COPPER REPLACEMENT THERAPY. LOW DOSE METHADONE WAS RECOMMENDED. ON (B)(6) 2008, ASSESSMENT INCLUDED CHRONIC NEUROPATHIC PAIN RELATED TO COPPER DEFICIENCY NEUROPATHY. ON (B)(6) 2008, THE PATIENT COMPLAINED OF PAIN AND NUMBNESS IN FEET AND HANDS. THE PATIENT WAS TREATED WITH HOMEOPATHIC LEDUM, VIPERA, AND MAGNESIUM PHOSPHORUS WITH IMPROVEMENT BY (B)(6) 2008. ON (B)(6) 2008, ZINC LEVEL WAS 80 (NORMAL 60 TO 130 MCG/DL). ON (B)(6) 2009, IT WAS NOTED THE PATIENT UNDERWENT TEETH EXTRACTION AND WAS FITTED FOR DENTURES IN (B)(6) 2003. HE BEGAN USING DENTURE CREAM (POLIGRIP) AT THAT TIME, APPLYING IT TO THE TOP AND BOTTOM PLACES IN THE MORNING AND THEN REPEATING THE APPLICATION TO THE LOWER DENTURE IN THE AFTERNOON. HE WAS USING THREE TUBES A WEEK. THE PATIENT HAD NEW DENTURES MADE TWO MONTHS AGO (APPROXIMATELY (B)(6) 2009) AND WAS ABLE TO DECREASE HIS DENTURE CREAM USE. HE ONLY USED IT ON THE BOTTOM DENTURES NOW. NOW, THE PATIENT ONLY USED ABOUT ONE TO ONE AND ONE-HALF TUBES PER WEEK. IN 2005, THE PATIENT WAS DIAGNOSED WITH ANEMIA (HEMOGLOBIN IN THE SEVEN TO NINE RANGE) AND LEUKOPENIA. THE PATIENT'S ANEMIA HAD IMPROVED TO NORMAL SINCE COPPER WAS STARTED, BUT THERE HAD BEEN NO IMPROVEMENT IN HIS NEUROPATHY SYMPTOMS. THE PATIENT FELT HIS BALANCE AND WEAKNESS HAD ACTUALLY WORSENED OVER THE PAST YEAR. THE PATIENT TOOK GABAPENTIN FOR PAIN WITH SOME BENEFIT, BUT STILL HAD SIGNIFICANT DISCOMFORT. IMPRESSION INCLUDED SENSORY PREDOMINANT POLYNEUROPATHY WITH BOTH LARGE AND SMALL FIBER LOSS. SINCE THERE WAS NO DOCUMENTATION OF HIGH LEVELS OF ZINC, THE PHYSICIAN COULD NOT IMPLICATE THE PATIENT'S USE OF DENTURE CREAM AS THE CAUSE OF THE HYPOCUPREMIA, THOUGH HE REPORTED USING LARGE AMOUNTS. THE PATIENT'S COPPER LEVEL HAD NORMALIZED. ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 111 (NORMAL 70 TO 155 UG/DL) AND ZINC LEVEL WAS 128 (NORMAL 70 TO 150 UG/DL).

    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