BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 2011901 · Received February 25, 2011

    Report

    Report Number
    9681138-2011-00052
    Event Type
    Other
    Date Received
    February 25, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 NERVE DAMAGE IN A PT WHO USED POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT USED POLIGRIP OF UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NERVE DAMAGE AND INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. MEDICAL RECORDS RECEIVED (B)(4) 2010: ON (B)(6) 2010, THE (B)(6) PT WAS RELEASED FROM A PAIN CENTER FOLLOWING ASSESSMENT FOR LOWER BACK AND LEG PAIN THAT HAD BEEN GOING ON FOR SIX YEARS PRIOR. THIS WAS DESCRIBED AS A SHARP BURNING PAIN WITH NUMBNESS AND TINGLING THAT WAS EXACERBATED WITH STANDING AND WALKING. AN EXTENSIVE WORKUP HAD BEEN DONE AT THE (B)(6), AND SHE HAD UNDERGONE A LAMINECTOMY FOR SPINAL STENOSIS AT THE L4-L5 LEVEL WITH MINIMAL IMPROVEMENT. SHE WAS TAKING OXYCONTIN, PERCOCET, GABAPENTIN, AND ULTRAM. DIAGNOSES INCLUDED CHRONIC PAIN SYNDROME, PERIPHERAL NEUROPATHY, AND DIFFUSE MYALGIAS. HER SYMPTOMS WERE UNCHANGED AT FOLLOW UP ON (B)(6) 2010. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2008, THE PT HAD RECENTLY FOUND TO HAVE PANCYTOPENIA. THE PT ALSO HAD A RECENT HISTORY OF ANEMIA AND LEUKOPENIA. ON (B)(6) 2008, THE PT'S FIBROMYALGIA AND NEUROPATHY WAS STILL BOTHERING HER. THE PANCYTOPENIA RESOLVED ON ITS OWN. ON (B)(6) 2009, THE PT HAD SOME ABNORMALITY IN COPPER METABOLISM. MEDICAL RECORDS RECEIVED (B)(4) 2010; AT A PHYSICIAN'S VISIT ON (B)(6) 2005, THE PT WAS NOTED TO HAVE SEVERE WORSENING PERIPHERAL NEUROPATHY FOR FOUR MONTHS PRIOR. SHE HAD THE START OF A FOOT DROP WITH QUADRICEPS WEAKNESS AND COULD NOT WALK WELL. THE PT'S HANDS BECAME INVOLVED, AND SHE HAD GLOVE-LIKE ANESTHESIA OF HER LOWER EXTREMITIES UP TO HER PELVIS. AT FOLLOW UP ON (B)(6) 2006, IT WAS NOTED THAT THE PHYSICIAN AND A NEUROLOGIST HAD "DONE ABOUT ANYTHING" TO COME UP WITH A DIAGNOSIS. A LOWER COPPER LEVEL HAD BEEN DISCOVERED, AND SHE HAD BEEN STARTED ON COPPER SUPPLEMENTATION. AT A VISIT ON (B)(6) 2006, IT WAS NOTED THAT MUSCLE BIOPSY SHOWED ATROPHY OF NEUROGENIC ETIOLOGY AND NERVE BIOPSY WAS POSITIVE, WHICH WAS FELT TO BE THE CAUSE OF HER EXTREME WEAKNESS. FOLLOW UP INFO WAS RECEIVED ON (B)(4) 2011 VIA MEDICAL RECORDS. ON (B)(6) 2008, THE PT'S COPPER LEVEL WAS 108 (NORMAL 70 TO 155 UG/DL) AND THE ZINC LEVEL WAS 156 (70 TO 250) UG/DL). ON (B)(6) 2009, IN THE NEUROPATHIC CLINIC, THE PT WAS EVALUATED FOR HER NEUROPATHY AND PRESUMED MYELOPATHY. THE PT HAD BEEN SEEN ON (B)(6) 2008 AND IT WAS FELT THAT SHE COULD HAVE A COPPER DEFICIENT MYELONEUROPATHY AND WAS BROUGHT THERE TO SEE IF ANYTHING COULD BE DONE TO IMPROVE HER LEVEL OF FUNCTION. SINCE HER LAST VISIT, THE PT COMPLAINED OF BALANCE DIFFICULTY AND WEAKNESS IN HER LEGS. IMPRESSION INCLUDED PRESUMED MYELONEUROPATHY. ELECTROMYOGRAPHY (EMG) NERVE CONDUCTION STUDIES SHOWED EVIDENCE OF MILD BILATERAL CARPAL TUNNEL SYNDROME. ON (B)(6) 2009, THE PHYSICIAN REPORTED THE PT SUFFERED FROM SEVERE AND ADVANCED PERIPHERAL MOTOR SENSORY NEUROPATHY RESOLVING IN SEVERE IMBALANCE WITH ANY WALKING AND SEVERE LOWER EXTREMITY WEAKNESS ASSOCIATED WITH SPASTICITY AND PAIN. AT AN UNK TIME, DIAGNOSES ALSO INCLUDED FIBROMYALGIA, ATAXIA, MYELOPATHY, AND SPASTIC PARAPLEGIA. ON (B)(6) 2009, THE PT WAS EVALUATED BY NEUROSURGERY AND DIAGNOSED WITH SCOLIOSIS AND LUMBAR STENOSIS. ON (B)(6) 2009, THE PT WAS EVALUATED IN A NEUROMUSCULAR RESEARCH CENTER. THE PT HAD USED DENTURES WITH A CREAM FOR 20 YEARS (SINCE APPROXIMATELY 1989). APPROXIMATELY 10 TO 15 YEARS AGO (SINCE APPROXIMATELY 1994 TO 1999), THE PT DEVELOPED LEG HEAVINESS AND THEN ABOUT SIX YEARS AGO (SINCE APPROXIMATELY 2003), THE PT DEVELOPED NUMBNESS. ELECTROPHYSIOLOGICAL TESTING IDENTIFIED ONLY A MILD NEUROPATHY. ON EVAL, AT LEAST A B12 DEFICIENCY AND COPPER DEFICIENCY WITH ZINC EXCESS IN THE BLOOD WERE IDENTIFIED. A PHYSICIAN AT THE (B)(6) DID NOT CONSIDER COPPER DEFICIENCY AS A POSSIBLE CAUSE AND ATTRIBUTED HER NEUROPATHY TO ALCOHOLISM AND CACHEXIA. HOWEVER, THE PT HAD A CLASSICAL MYELONEUROPATHY WITH LARGE FIBER DYSFUNCTION IN THE LOWER EXTREMITIES, BRISK REFLEXES AT THE KNEES, ABSENT ANKLE REFLEXES, AND NERVE CONDUCTION SHOWING ONLY AN ABSENCE OF SURAL SENSORY RESPONSES SUGGESTING DORSAL COLUMN SPINAL CORD DYSFUNCTION IN ADDITIONAL TO A NEUROPATHY. NERVE BIOPSY IN THE PAST HAD CONFIRMED THE PRESENCE OF AXONAL CHANGES WITHOUT ANY INFLAMMATION. AFTER HAVING NO IMPROVEMENT WITH THE SHORT USE OF COPPER AND B12 SHOTS, THE PT HAD ABANDONED THE USE OF BOTH B12 AND COPPER USAGE FOR AT LEAST THE LAST THREE TO FOUR YEARS AND HER NEUROPATHY HAD CONTINUED TO GET WORSE. IMAGING STUDIES OF THE CERVICAL SPINE HAD SHOWN SIGNAL CHANGES WHICH WAS INITIALLY ATTRIBUTED TO A SYRINX, BUT THE PHYSICIAN SUSPECTED THEY WERE SIGNAL CHANGES IN THE DORSAL COLUMN SEEN OFTEN WITH B12 DEFICIENCY AND COPPER DEFICIENCY. A CERVICAL AND THORACIC SPINE MAGNETIC RESONANCE IMAGING HAD EXCLUDED A STRUCTURAL MYELOPATHY. A LUMBAR SPINAL STENOSIS WAS FOUND AND SURGICALLY CORRECTED WITHOUT ANY IMPROVEMENT. THORACIC KYPHOSIS WAS IDENTIFIED. THE PT HAD SPEECH DIFFICULTY, OCCASIONAL VISUAL PROBLEMS, MUSCLE WASTING, WEAKNESS, AND QUITE A PROFOUND LOSS OF WEIGHT, MAINLY BECAUSE OF THE FACT THAT SHE WAS UNABLE TO CHEW WITH DENTURES. THE PT HAD NEVER STOPPED USING THE DENTURE CREAMS FOR THE LAST 20 YEARS. B12 AND COPPER SUPPLEMENTATION WAS DISCONTINUED APPROXIMATELY THREE YEARS AGO AFTER HAVING ONLY BEEN USED FOR LESS THAN A YEAR. THE PT WAS ASKED TO STOP USING DENTURE CREAM. ON (B)(6) 2009, THE COPPER LEVEL WAS 16 AND ZINC WAS 153, ON (B)(6) 2009, THE PT HAD BEEN UNABLE TO STOP THE DENTURE CREAM USE BECAUSE SHE COULD CHEW. THE PT WAS STILL USING THE DENTURES WHILE WAITING FOR THE PLACEMENT OF PERMANENT TEETH. COPPER REPLACEMENT HAD CONTINUED. THE PT HAD STOPPED THE B6 DUE TO HIGH LEVELS OF B6 AND EXCESS ZINC. B12 LEVELS WERE CURRENTLY NORMAL. COPPER WAS STILL DEFICIENT BASED ON LABS. THE PT HAD HAD REPLACEMENT FOR A MONTH. ON (B)(6) 2009, THE COPPER LEVEL WAS NORMAL. ON (B)(6) 2010, A MAGNETIC RESONANCE IMAGING (MRI) OF THE LUMBAR SPINE SHOWED L4/5 SUBTLE GRADE 1 ANTEROLISTHESIS WITH DISK BULGING CAUSING MILD FLATTENING OF THE THECAL SAC ALONG WITH ABUTMENT/IMPINGEMENT OF THE EXITING RIGHT L4 NERVE ROOT, L3/4 MILD SPINAL STENOSIS, L5/S1 DISK BULGE CAUSING FLATTENING OF THE THECAL SAC, AND DEXTROSCOLIOSIS WITH SUBSEQUENT SPONDYLOTIC CHANGES AT L1/2 AND L2/3, AS WELL.

    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 71 YR Other