BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL

    MDR report key: 1790951 · Received August 4, 2010

    Report

    Report Number
    9681138-2010-00281
    Event Type
    Other
    Date Received
    August 4, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    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, CURRENTLY (B)(6), WHO RECEIVED SUPER POLIGRIP ORIGINAL ((B)(4)) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. APPROXIMATELY 35 YEARS PRIOR TO REPORTING, THE PATIENT BEGAN USING DENTURES AND HER DENTURE ADHESIVES OF CHOICE WERE SUPER POLIGRIP ORIGINAL AND FIXODENT. ACCORDING TO THE CLAIM, THE PATIENT "NOW SUFFERS SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." ACCORDING TO THE CLAIM, THE PATIENT WAS "UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES." THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2007, THE PATIENT HAD A FALL AT WORK AND INJURED HER LEFT HAND AND WRIST. THE PATIENT HAD A POSSIBLE NON-DISPLACED FRACTURE OF THE PROXIMAL PHALANX OF THE FIFTH FINGER. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2007 FOR RIGHT SIDED NUMBNESS AND POSSIBLE TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT COMPLAINED OF SOME RIGHT HAND NUMBNESS AND UPPER LIP SWELLING APPROXIMATELY ONE WEEK AGO. ON (B)(6) 2007, THE PATIENT DEVELOPED A GRADUAL ONSET OF RIGHT HAND NUMBNESS THAT PROGRESSED TO HER RIGHT BICEPS. SHE THEN DEVELOPED TINGLING IN HER RIGHT FOOT ON (B)(6) 2007, WHICH WAS ACCOMPANIED BY NUMBNESS AND RADIATED UP TO HER RIGHT SIDE THROUGHOUT THE DAY. SHE THEN FELT NUMBNESS IN HER RIGHT LOWER ABDOMINAL QUADRANT. A BRAIN MAGNETIC RESONANCE IMAGING (MRI) AND CAROTID DOPPLERS WERE UNREMARKABLE. A CERVICAL SPINE MRI SHOWED A DISC PROTRUSION ON THE RIGHT SIDE OF C5/6 AND A MILD WIDENING OF THE CERVICAL SPINAL CORD WITH ABNORMAL T2 SIGNAL HYPERINTENSITY AT THE C2 THROUGH C6 LEVELS. ACCORDING TO THE PHYSICIAN, THE PATIENT'S FINDINGS WERE UNIMPRESSIVE AND ESSENTIALLY NON-FOCAL. ON (B)(6) 2007, THE PATIENT WAS SEEN IN AT A BRAIN AND SPINE CENTER. THE PATIENT REPORTED A FALL IN MID (B)(6), INJURING HER LEFT HAND AND STRIKING HER HEAD ON THE GROUND. THE PATIENT'S RIGHT-SIDED WEAKNESS WAS PROGRESSIVELY WORSENING. SHE HAD DIFFICULTY WRITING/HOLDING OBJECTS WITH HER LEFT HAND AND SHE WAS UNABLE TO CONTROL WHAT SHE WAS DOING. ON (B)(6) 2007, THE PATIENT REPORTED THE SYMPTOMS STARTED A WEEK OR TWO AFTER THE FALL. IMPRESSION INCLUDED CERVICAL CORD LESION. ON (B)(6) 2007, THE PATIENT UNDERWENT A LUMBAR PUNCTURE WITH RESULTS PENDING. THE PATIENT WAS ABLE TO AMBULATE BUT THE NUMBNESS AND WEAKNESS IN HER RIGHT ARM WERE DEBILITATING. THE PATIENT WAS REFERRED TO A NEUROLOGIST. A DIAGNOSIS OF TRANSVERSE MYELITIS WAS DISCUSSED. ON (B)(6) 2007, THE PATIENT WAS SEEN BY A NEUROLOGIST. THE PATIENT WAS ALSO HAVING SPEECH PROBLEMS AND IT WAS DIFFICULT TO UNDERSTAND HER OVER THE PHONE. HER PREVIOUS CERVICAL SPINE MRI WAS RE-EXAMINED AND DID SHOW A MID CERVICAL LESION. THE PHYSICIAN WAS CONCERNED ABOUT LUPUS OR A PRENEOPLASTIC SYNDROME. ON (B)(6) 2007, THE PATIENT HAD THE APPEARANCE OF MYELOPATHY AND WAS DYSARTHRIC. THE PATIENT WAS REFERRED FOR A SECOND OPINION. ON (B)(6) 2007, THE PATIENT WAS UNABLE TO WALK. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2007 WITH PRINCIPAL DIAGNOSIS OF TRANSVERSE MYELITIS LIKELY DUE TO SJOGREN'S SYNDROME, PARAPARESIS DUE TO TRANSVERSE MYELITIS, OSTEOPENIA, BLADDER DYSFUNCTION, AND URINARY TRACT INFECTION. ON (B)(6) 2007, A BRAIN MRI SHOWED EXTENSIVE T2 HYPERINTENSE SIGNAL BEGINNING AT THE LEVEL OF C3/4 EXTENDING THROUGHOUT THE THORACIC CORD. ENHANCEMENT OF THE CORD BEGAN AT APPROXIMATELY T1 AND WAS SOMEWHAT PATCHY, ALTHOUGH EXTENDED CONTINUOUSLY THROUGHOUT THE THORACIC CORD. THESE FINDINGS WERE SUGGESTIVE OF TRANSVERSE MYELITIS. SEVERAL DAYS AFTER THE PATIENT'S HOSPITALIZATION IN (B)(6) 2007, THE PATIENT BEGAN EXPERIENCING "SPASMS" WHEREBY HER RIGHT ARM WOULD JERK INTO A DECORTICATE POSTURE AND HER RIGHT FOOT WOULD INVERT. THIS DYSTONIA LASTED ONE MINUTE AND WAS ACCOMPANIED BY "TINGLING ALL OVER," SENSATION THAT PERSISTED FOR TWO TO THREE MINUTES. THE SPASTIC EPISODES OCCURRED ONCE AN HOUR, WITHOUT A SPECIFIC TRIGGER. OVER THE NEXT TWO MONTHS, NUMBNESS AND SPASTIC WEAKNESS GRADUALLY SPREAD TO HER LEFT LEG. THE PATIENT WAS DIAGNOSED WITH TRANSVERSE MYELITIS OF C4/C5 WITH RESULTANT RIGHT SPASTIC GAIT, DYSTONIC RIGHT POSTERING, SPARING SPHINCTER FUNCTION, AND NO SPINAL SENSORY LEVEL. THE PATIENT WAS TREATED WITH METHYLPREDNISOLONE, DIALYSIS, AND INTRAVENOUS CYTOXAN. THE PATIENT REMAINED PARAPLEGIC IN BOTH LEGS DESPITE THESE INTERVENTIONS AND DID NOT APPEAR TO HAVE ANY SENSATION IN EITHER LEG. HER PROGNOSIS REMAINED VERY POOR AND SHE REQUIRED EXTENSIVE REHABILITATION. ON (B)(6) 2008, A MRI OF THE CERVICAL SPINE SHOWED CONTINUED SIGNAL IRREGULARITY OF THE CERVICAL CORD, BUT THE DEGREE OF ENLARGEMENT/ENHANCEMENT/AND INCREASED T2 SIGNAL HAD GREATLY DECREASED FROM THE PRIOR STUDY DATED (B)(6) 2007. ON (B)(6) 2008, THE PATIENT COULD NOT USE HER LEGS AT ALL. ON (B)(6) 2008, IT WAS NOTED THE PATIENT HAD COMPLETED SIX ROUNDS OF INTRAVENOUS CYTOXAN WITH IMPROVING STRENGTH IN LEGS AND NUMBNESS IN HANDS. IMPRESSION INCLUDED OSTEOPENIA AND URINARY INCONTINENCE. ON (B)(6) 2008, THE PATIENT HAD SOME IMPROVEMENT OF MOVEMENT AND STRENGTH OF LOWER EXTREMITIES AND WAS IN REHAB. THE PATIENT WAS ABLE TO WALK SOME WITH ASSISTANCE, BUT WAS STILL WHEELCHAIR BOUND. MOVEMENT OF LEGS WAS ABSENT PRIOR. THE PATIENT HAD GOOD CONTROL OF BOWELS AND IMPROVING CONTROL OF BLADDER. IMPRESSION INCLUDED SPASTIC QUADRIPARESIS AND CERVICAL MYELOPATHY SECONDARY TO LESIONS SJOGREN'S. ON (B)(6) 2009, THE PATIENT WAS ABLE TO AMBULATE UNASSISTED WITH A WALKER, BUT USED A MOTORIZED WHEELCHAIR. ON (B)(6)2009, THE PATIENT WAS SEEN BY RHEUMATOLOGY FOR FOLLOW UP OF TRANSVERSE MYELITIS AND SJOGREN'S SYNDROME (SS). ON (B)(6) 2009, THE PATIENT CONTINUED IMURAN AND BACLOFEN. THE PATIENT STATED HER LEGS FELT BETTER SINCE BEGINNING HOME PHYSICAL THERAPY. THE PATIENT REPORTED RIGHT HAND NUMBNESS THAT HAD INTENSIFIED OVER THE PAST TWO TO THREE DAYS. THE PATIENT WAS ABLE TO STAND WITH ASSISTANCE. ON (B)(6) 2009, AN ELECTROMYOGRAPHY (EMG) SHOWED A MILD RIGHT MEDIAN SENSORY NEUROPATHY AND MILD RIGHT ULNAR NERVE DYSFUNCTION. ON (B)(6) 2010, THE PATIENT REPORTED SPASMS THAT OCCURRED ALMOST EVERY NIGHT IN HER LOWER EXTREMITIES. THE PATIENT CONTINUED HOME PHYSICAL THERAPY. THE PATIENT WAS NOW WEARING BILATERAL WRIST SPLINTS FOR CARPAL TUNNEL SYNDROME, WHICH RELIEVED THE TINGLING IN HER HANDS. A URINE ZINC LEVEL WAS 1745 (NORMAL 300 TO 600 UG/SPEC). THE PATIENT STATED HER ZINC LEVEL RETURNED TO NORMAL AFTER DISCONTINUING POLIGRIP ADHESIVE. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH LEUKOPENIA, MILD DOSE-RELATED MARROW SUPPRESSION FROM AZATHIOPRINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization FIXODENT