BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1912774 · Received November 3, 2010

    Report

    Report Number
    9681138-2010-00375
    Event Type
    Other
    Date Received
    November 3, 2010
    Report Date
    November 3, 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 NERVE INJURY IN A MALE 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 AT UNK DOSING. AT AN UNK TIME AFTER USING POLIGRIP, THE PT EXPERIENCED NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PT HAD BEEN SEEN IN THE HOSPITAL FOR PARESTHESIAS IN THE RIGHT HAND AND RIGHT EAR. THE PT LEFT AGAINST MEDICAL ADVICE WHILE THERE AND HAD TO BE CALLED AT HOME TO COME BACK FOR A GADOLINIUM STUDY. THE PT HAD SIGNS OF TRAUMA ON MAGNETIC RESONANCE IMAGING (MRI) AND POSSIBLE REMOTE TRAUMA WITH POSTTRAUMATIC SYRINX AS THE MOST LIKELY DIAGNOSIS AFTER REVIEWING THE FILMS. THE PT WAS REFERRED TO A SPINE SURGEON. ON (B)(6) 2009, IT WAS REPORTED THE PT HAD A REMOTE HISTORY, 10 YEARS AGO, WHERE HE WAS "PARALYZED" FOR ABOUT EIGHT MONTHS. HE RECEIVED INTRAVENOUS ANTIBIOTICS, POSSIBLY OSTEOMYELITIS. IT WAS BELIEVED THE PT PROBABLY HAD A REMOTE SPINAL INFECTION 10 YEARS AGO, PERHAPS TRAUMA LEADING TO THIS CHRONIC SEQUEL ON HIS MAGNETIC RESONANCE IMAGING (MRI) INCLUDING MYELOMALACIA AND SYRINX. THE PT HAD A HISTORY OF POLYSUBSTANCE ABUSE AND LONGSTANDING CHRONIC INFECTION OF RIGHT LOWER EXTREMITY. IMPRESSION INCLUDED CHRONIC MYELOMALACIA WITHOUT ANY PATHOLOGIC ENHANCEMENT TO SUGGEST INTRAMEDULLARY TUMOR. ON (B)(6) 2009, THE PT WAS NOTED TO HAVE A HISTORY OF PARESTHESIAS D4/D5 AND SEIZURES THAT HAD BEEN GOING ON FOR SOME TIME. IMPRESSION INCLUDED ELECTROPHYSIOLOGIC EVIDENCE OF A MEDIAN NERVE ENTRAPMENT ACROSS THE RIGHT WRIST THAT WAS MILD, BASED ON TRANSCARPAL SLOWING WITHOUT SENSORIMOTOR AXONAL LOSS. CLINICALLY, THE PT WAS ASYMPTOMATIC IN THIS DISTRIBUTION AND THIS WAS LIKELY AN INCIDENTAL FINDING. THERE WAS ELECTROPHYSIOLOGIC EVIDENCE OF ULNAR NERVE ENTRAPMENT ACROSS THE RIGHT ELBOW. THIS WAS MILD AND BASED SOLELY ON MILD SENSORY AXONAL LOSS AND FOCAL SLOWING ACROSS THE ELBOW VIA MOTOR STUDIES. THERE WAS NO MOTOR AXONAL LOSS AND THIS WAS CONSISTENT WITH A MILD RIGHT-SIDED CUBITAL TUNNEL SYNDROME. ELECTROMYOGRAPHY (EMG) NEEDLE STUDY WAS NOT PERFORMED AT THE PT'S REQUEST. ON (B)(6) 2010, THE PT'S SERUM COPPER LEVEL WAS 27 (NORMAL 70 TO 155 UG/ML), CERULOPLASMIN LEVEL WAS 7.5 (NORMAL 16.2 TO 35.6 MG/DL) AND SERUM ZINC LEVEL WAS 127 (NORMAL 70 TO 150 UG/DL). ON (B)(6) 2010, THE PT WAS SEEN FOR EVAL OF MYELONEUROPATHY, PARESTHESIAS IN BILATERAL UPPER EXTREMITIES, AND CERVICAL SYRINX AT C4/C6. THE PT'S COPPER AND CERULOPLASMIN LEVELS WERE MARKEDLY REDUCED AND ZINC LEVEL WAS HIGH NORMAL. THE PT HAD BEEN USING POLIGRIP AND FIXODENT THREE TO FOUR TIMES A DAY FOR OVER 15 YEARS. THE PT HAD NUMBNESS AND TINGLING IN HIS FEET AND GAIT IMBALANCE. PREVIOUS MAGNETIC RESONANCE IMAGING (MRI) OF THE CERVICAL SPINE SHOWED T2 SIGNAL WITHIN THE INTRAMEDULLARY CERVICAL CORD. THE PT WAS MARKEDLY ANEMIC AND FOLLOWED BY ANOTHER PHYSICIAN FOR THIS. THE ANEMIA WAS BELIEVED TO BE ASSOCIATED WITH COPPER DEFICIENCY. INTRAVENOUS COPPER WAS STARTED, FOLLOWED BY AN ORAL TAPER. ON (B)(6) 2010, THE PT WAS TAKING ORAL COPPER SUPPLEMENTATION. ON (B)(6) 2010, THE PT HAD NUMBNESS IN LOWER EXTREMITIES FOR SOME TIME AND MULTIPLE RECURRENT ULCERS. ELECTROPHYSIOLOGIC EVIDENCE WAS SUPPORTIVE OF A SIGNIFICANT SENSORIMOTOR POLYNEUROPATHY PREDOMINANTLY OF THE AXONAL TYPE WITH SOME DEMYELINATING FEATURES. ON (B)(6) 2010, COPPER LEVEL WAS 137 (NORMAL 70 TO 155 UG/DL) AND ZINC LEVEL WAS 92 (NORMAL 70 TO 150 UG/DL). ON (B)(6) 2010, THE PT CONTINUED TO HAVE TINGLING IN HIS HAND AND FEET WHICH WAS FUNCTIONALLY IMPAIRING. THE PT WAS USING THE NEW SUPER POLIGRIP WITHOUT ZINC. HE WAS TAKING COPPER SULFATE DAILY. LYRICA WAS ADDED. ON (B)(6) 2010, IT WAS NOTED THE PT WAS ORIGINALLY EVALUATED IN 2009 FOR SEVERE NECK PAIN. HE WAS FOUND TO HAVE CERVICAL "SYRINX" WITH MYELOMALACIA AT C5/C6. HE ALSO HAD VERY FREQUENT CELLULITIS. THE PT WAS DIAGNOSED WITH NEUROPATHY. THE NEUROPATHY WAS MODERATELY SEVERE SENSORIMOTOR POLYNEUROPATHY FROM THE AXONAL TYPE WITH SOME DEMYELINATING FEATURES. THE PT WAS FOUND TO HAVE COPPER DEFICIENCY CLEARLY PROVEN WITH LOW COPPER LEVEL, HIGH ZINC LEVEL, AND LOW CERULOPLASMIN LEVEL. THE PT WAS FOUND TO HAVE AN ELEVATED ZINC LEVEL RELATED TO HIS DENTURE CREAM AND WAS CURRENTLY UNDER TREATMENT. THE PT STOPPED USING DENTURE CREAMS WITH ZINC. HIS FOLLOW UP COPPER LEVEL WAS MUCH BETTER. HE WAS ON VARIOUS PAIN MEDICATIONS INCLUDING NARCOTICS AND NEUROPATHIC PAIN MEDICATION TO HELP CONTROL HIS PAIN. GIVEN HIS SIGNIFICANT NEUROPATHY AND SEVERE NECK PAIN, THE PT HAD DIFFICULTY FUNCTIONING AT ANY CAPACITY FOR A PERIOD OF TIME AND WAS UNABLE TO WORK AT THIS TIME. IMPRESSION INCLUDED MYELONEUROPATHY RELATED TO COPPER DEFICIENCY SECONDARY TO DENTURE CREAM USE. ON (B)(6) 2010, COPPER LEVEL WAS 130 (NORMAL 70 TO 155 UG/DL) AND ZINC LEVEL WAS 77 (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 Hospitalization| S FIXODENT