BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/POLIGRIP

    MDR report key: 2093587 · Received April 19, 2011

    Report

    Report Number
    9681138-2011-00095
    Event Type
    Other
    Date Received
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NERVE 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 UNSPECIFIED NEUROLOGICAL INJURIES. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2005, COPPER LEVEL WAS 50 AND ZINC LEVEL WAS 1569. ON (B)(6) 2005, A MAGNETIC RESONANCE IMAGING (MRI) OF THE CERVICAL SPINE SHOWED MYELOPATHY, WHICH WAS MOST LIKELY NON-COMPRESSIVE. ON (B)(6) 2006, THE PATIENT HAD A NEUROLOGICAL EVALUATION AND REPORTED HAVING SYMPTOMS IN (B)(6) 2005. THE PATIENT HAD NUMBNESS IN HER HANDS AND FEET, WHICH BECAME PROGRESSIVE. ON (B)(6) 2006, A BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED WHITE MATTER SIGNAL ABNORMALITIES, RAISING THE POSSIBILITY OF A DEMYELINATION DISORDER. ON (B)(6) 2006, THE PATIENT WAS NOTED TO HAVE A HISTORY OF IRON DEFICIENCY ANEMIA ((B)(6) 2005), ANEMIA ((B)(6) 2005), A LOW B12 LEVEL ((B)(6) 2005 AND TREATED WITH B12), LEUKOPENIA ((B)(6) 2005), AND BONE MARROW BIOPSY CONSISTENT WITH MYELODYSPLASTIC SYNDROME ((B)(6) 2005 AND TREATED WITH ARANESP). THE PATIENT DEVELOPED PROGRESSIVE DIFFICULTY WITH GAIT DISTURBANCE AND WAS FOUND TO HAVE EVIDENCE OF COPPER DEFICIENCY AND WAS GIVEN COPPER SUPPLEMENTS, BUT WAS WITHOUT ANY CHANGE IN HER NEUROLOGICAL SYMPTOMS. AN ELECTROMYOGRAM (EMG) WAS NORMAL IN (B)(6) 2005. A MAGNETIC RESONANCE IMAGING (MRI) SHOWED FINDINGS CONSISTENT WITH MYELOPATHY. THE PATIENT WAS ALSO FOUND TO HAVE A HIGH ZINC LEVEL, BUT HAD BEEN ON ZINC SUPPLEMENTS 40 MG PER DAY FOR ABOUT A YEAR PRIOR (SINCE 2005). THE PATIENT WAS REFERRED TO EVALUATE THE POSSIBILITY OF MALABSORPTION. THE PATIENT INITIALLY HAD A SUBTOTAL GASTRECTOMY APPROXIMATELY 14 YEARS AGO (APPROXIMATELY 1992) BECAUSE OF ULCER DISEASE, DEVELOPING A PERFORATED ULCER WHILE TAKING ASPIRIN. THE NEUROLOGICAL PROBLEM HAS BEEN PRESENT SINCE AT LEAST MAY 2005, DESCRIBED AS GENERALIZED WEAKNESS IN LEGS AND WITH GAIT DISTURBANCE. THE PATIENT HAD A PERIPHERAL NEUROPATHY. ON (B)(6) 2006, A BONE MINERAL DENSITY EXAMINATION SHOWED MILD TO MODERATE OSTEOPENIA OF THE LUMBAR SPINE AND SEVERE OSTEOPENIA OF THE LEFT FEMORAL NECK. ON (B)(6) 2006, THE PATIENT'S MYELOPATHY AND SIDEROBLASTIC ANEMIA WERE CONSIDERED RELATED TO A COPPER DEFICIENCY. THE PATIENT HAD COMPLETED COPPER REPLACEMENT AND HER MYELOPATHIC SYMPTOMS HAD BEEN IMPROVING, BUT HAD NOT RESOLVED. THE NUMBNESS THAT THE PATIENT ONCE EXPERIENCED FROM THE WAIST DOWN WAS NOW FELT ONLY FROM THE KNEE DOWN. IN GENERAL, HER SENSATION "APPEARED" TO BE IMPROVING. ON (B)(6) 2007, COPPER LEVEL WAS 275 UG/L (NORMAL 510 TO 1610) AND ZINC LEVEL WAS 1898 UG/L (NORMAL 700 TO 1200). ON (B)(6) 2007, THE PATIENT CONTINUED TO DO WELL, BUT HER NEUROPATHIC SYMPTOMS PERSISTED. COPPER AND CERULOPLASMIN LEVELS WERE NORMAL. ON (B)(6) 2007, THE PATIENT RETURNED FOR FOLLOW UP OF HER MYELOPATHY AND CYTOPENIAS, WHICH WERE ASSUMED TO BE RELATED TO A COPPER DEFICIENCY AND ZINC EXCESS. ON (B)(6) 2008, A COPPER LEVEL WAS 1014 MCG/L (510 TO 1610) AND ZINC LEVEL WAS 2041 MCG/L (700 TO 1200). ON (B)(6) 2008, THE PATIENT CONTINUED TO RECEIVE B6, B12, AND FOLIC ACID, AS WELL AS ORAL COPPER REPLACEMENT. THE PATIENT FELT THE PARESTHESIA AND WEAKNESS THAT AFFECTED HER HANDS WERE GETTING BETTER. SHE WAS AMBULATING WITH A WALKER AND FELT THAT HER GAIT WAS STEADIER AS WELL. ON (B)(6) 2009, ASSESSMENT INCLUDED POLYNEUROPATHY SECONDARY TO ZINC TOXICITY. ON (B)(6) 2009, THE PATIENT RETURNED FOR FOLLOW UP OF HER COPPER DEFICIENCY WITH RELATED MYELOPATHY. INCIDENTALLY, SHE WAS RECENTLY HOSPITALIZED WITH EVIDENCE OF GASTROINTESTINAL BLEEDING ((B)(6) 2009). THE PATIENT REPORTED HER LEGS WERE LESS NUMB AND SHE WONDERED WHETHER THIS IMPROVEMENT MIGHT CORRESPOND TO A GRADUAL DROP IN HER SERUM ZINC LEVELS WHICH WERE IDENTIFIED RECENTLY. THE PATIENT'S MOST RECENT ZINC LEVEL WAS AROUND 1250. THE PATIENT SHOWED EVIDENCE OF AN IRON DEFICIENCY STATE AND WAS STARTED ON ORAL IRON. ON (B)(6) 2010, DENTURE PASTE WAS RECENTLY IDENTIFIED AS A POSSIBLE SOURCE OF LONG-TERM ZINC EXPOSURE. THE PATIENT HAD BEEN TAKING THE SAME BRAND OF DENTAL PASTE FOR 19 YEARS AND IT WAS AMONG THOSE KNOWN TO CONTAIN SIGNIFICANT LEVELS OF ZINC. THE PATIENT RECENTLY DISCONTINUED USING THIS PASTE IN (B)(6) 2009, IDENTIFIED AS POLIGRIP (FORMULATION UNKNOWN). THE NUMBNESS INVOLVING HER HANDS HAD IMPROVED, BUT SHE CONTINUED TO EXPERIENCE ATAXIA AND NEEDED A WALKER TO AMBULATE OUTDOORS. ON (B)(6) 2010, DIAGNOSES INCLUDED MYELONEUROPATHY ASSOCIATED WITH HYPERZINCEMIA AND COPPER DEFICIENCY. THE PATIENT'S INITIAL NEUROLOGICAL WORK UP REVEALED A NORMAL EMG IN (B)(6) 2005. MRI OF THE CERVICAL SPINE WAS SIGNIFICANTLY ABNORMAL REVEALING THE PRESENCE OF INCREASED T2 SIGNAL WITHIN THE CORD SUBSTANCE FROM C2/3 TO C6/7, SUCCINCT WITH MYELOPATHY. THE THORACIC AND LUMBAR SPINES WERE UNREMARKABLE. A MRI OF THE BRAIN IN (B)(6) 2006, SHOWED T2 AND FLARE ABNORMALITIES IN THE PERIVENTRICULAR AND SUBCORTICAL REGIONS WITH SOME INVOLVEMENT OF THE CORPUS CALLOSUM. THE PATIENT'S PARESTHESIAS IN THE LIMBS HAD INCREASED OVER THE YEARS, NOW ALL THE WAY UP THE LEGS INTO THE BUTTOCKS REGION, AND INCREASING PARESTHESIAS IN THE HANDS. SINCE (B)(6) 2009, THESE PARESTHESIAS HAD ACTUALLY DIMINISHED. SHE CONTINUED TO HAVE PARESTHESIAS, BUT THEY WERE PRIMARILY IN THE FEET AND TOES. SHE CONTINUED TO WALK WITH A VERY WIDE-BASED GAIT AND MUST USE A WALKER AT HOME IN ORDER TO EFFECTIVELY AMBULATE. SHE DID ALL ACTIVITIES SEATED. ON (B)(6) 2010, THE PATIENT'S ZINC AND COPPER LEVELS WERE NORMAL. THE DENTAL PASTE WAS DETERMINED TO BE THE SOURCE OF THE ZINC OVERLOAD. ON (B)(6) 2010, AN EMG AND NERVE CONDUCTION STUDIES SHOWED NO ABNORMALITIES. ON (B)(6) 2010, A RECENT CERVICAL MRI SUGGESTED PERSISTENT MYELOPATHY WITHOUT MUCH RADIOGRAPHIC CHANGE. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS AFTER FURTHER ASSESSMENT BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other