Description of Event or Problem · 1
THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT AND DESCRIBED THE OCCURENCE OF INJURY IN A FEMALE PATIENT WHO USED SUPER POLIGRIP 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 AN UNSPECIFIED INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. MEDICAL RECORDS RECEIVED (B)(6) 2011: ON (B)(6) 2009, THE (B)(6), PATIENT, WAS SEEN DUE TO LOWER EXTREMITY NUMBNESS AND SEVERE GAIT IMPAIRMENT. THE PATIENT BEGAN HAVING NEUROLOGIC SYMPTOMS AFTER A SEVERE EPISODE OF LEFT UPPER QUADRANT ABDOMINAL PAIN OR LEFT LOWER RIB CAGE PAIN IN APPROXIMATELY 2002. SHE WAS FOUND TO HAVE KIDNEY STONES, BUT IT WAS NOT THOUGHT TO BE THE CAUSE OF HER PAIN SYNDROME. THE TINGLING AND NUMBNESS SENSATION BEGAN AT THAT TIME, AND SHE DESCRIBED THIS AS PAINFUL AND SLOWLY PROGRESSIVE OVER YEARS. THE NUMBNESS SPREAD UP HER LEGS TOWARD THE RIBCAGE, AND IT WAS NOTED THAT SHE HAD A NUMBER OF SOFT TISSUE PROBLEMS REQUIRING A RHEUMATOLOGIC EVALUATION. THE PATIENT HAD SIGNIFICANT LEFT HAND TENDON DAMAGE WHICH SOUNDED TO THE NEUROLOGIST AS SOME SORT OF TENDON TRANSFER FROM THE LEG TO HER ARM. SHE ALSO HAD SPASMS IN THE LEFT INDEX FINGER AND "A METAL BRUSH" PAINFUL SENSATION IN HER HANDS. THE PATIENT ALSO HAD DIZZINESS, POOR BALANCE, AND FELL FOUR TO FIVE TIMES DAILY DUE TO LOSS OF POSTURAL TONE. EMG AND NERVE CONDUCTION STUDIES WERE ABNORMAL SHOWING SENSORY LOSS. MYELONEUROPATHY WAS DIAGNOSED, AND EXTENSIVE LAB TESTING WAS ORDERED INCLUDING COPPER AND ZINC LEVELS. AT FOLLOW UP ON (B)(6) 2009, IT WAS NOTED THAT PATIENT HAD DISCONTINUED ZINC-CONTAINING DENTURE ADHESIVE AND STARTED ON COPPER AND B12 SUPPLEMENTATION SINCE THE LAST VISIT WITH NO IMPROVEMENT. HER CONDITION HAD DETERIORATED AND SHE REQUIRED USE OF A CANE AND WHEELCHAIR AND CONTINUED TO FALL RESULTING IN INJURIES. ZINC LEVEL WAS 145 AND COPPER WAS 68. THE NEUROLOGIST RECOMMENDED HOSPITALIZATION FOR FURTHER EVALUATION AND REHABILITATION AT THAT TIME, BUT THIS WAS REFUSED. ON (B)(6) 2009, THE PATIENT WAS SEEN FOR ONCOLOGY CONSULTATION REGARDING B12 DEFICIENCY. HER SYMPTOMS HAD PROGRESSED, AND SHE CONTINUED ON COPPER SUPPLEMENTATION. PROGRESSION OF SYMPTOMS CONTINUED AT FOLLOW UP VISITS THROUGH (B)(6) 2010. SHE WAS NOTED TO HAVE A VITAMIN D DEFICIENCY DURING THIS TIME. AT FOLLOW UP ON (B)(6) 2010, THE PATIENT CONTINUED TO HAVE DWINDLING NEUROLOGIC FUNCTION AND HAD BEEN HOSPITALIZED IN (B)(6) 2010. THE PATIENT HAD BEEN RECEIVING IN-HOME CARE AND OCCUPATIONAL THERAPY FROM (B)(6) 2010. OVERALL THE PATIENT APPEARED TO BE WEAKER WITH GREATER SENSORY DISTURBANCE AND WORSENING NEUROPATHY. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR THE LOT NUMBER WAS AVAILABLE. (B)(4).