BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1943811 · Received December 21, 2010

    Report

    Report Number
    9681138-2010-00417
    Event Type
    Other
    Date Received
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER VIA A TOLLING AGREEMENT, AND DESCRIBED THE OCCURRENCE OF NERVE INJURY IN A PT WHO USED POLIGRIP DENTURE ADHESIVE CREAM (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING POLIGRIP. AT AN UNK TIME AFTER STARTING POLIGRIP, THE PT EXPERIENCED "NEUROLOGICAL INJURIES" (NERVE INJURY). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. F/U INFO WAS RECEIVED ON (B)(6) 2010 VIA MEDICAL RECORDS. ON (B)(6) 2002, THE PT WAS SEEN IN CONSULTATION BY NEUROLOGY WITH COMPLAINTS OF RIGHT ELBOW PAIN AND TINGLING/NUMBNESS OF RIGHT HAND FOR THE PAST SEVEN TO EIGHT YEARS (SINCE APPROX 1994 TO 1995). THESE SYMPTOMS HAVE WORSENED OVER THE LAST YEAR (SINCE 2001). THE PT WAS NOW COMPLAINING OF DECREASED GRIP STRENGTH WITH DIFFICULTY OPENING AND CLOSING JAR LIDS/DOOR KNOBS. THE PT HAD A HISTORY OF MIGRAINE HEADACHES. ASSESSMENT INCLUDED RULE OUT ULNAR NERVE NEUROPATHY VERSUS CARPAL TUNNEL SYNDROME. ON (B)(6) 2002, ELECTROMYOGRAPHY (EMG) STUDY WAS NORMAL. ON (B)(6) 2009, THE PT WAS SEEN IN F/U OF HER ANEMIA AND LEUKOPENIA PRESUMED TO BE DUE TO COPPER DEFICIENCY FROM ZINC TOXICITY. THE PT WAS IN HER USUAL STATE OF HEALTH UNTIL (B)(6) 2008, WHEN SHE STARTED HAVING SOME LOWER ABDOMINAL AND BACK PAIN. THE PT WAS HOSPITALIZED AND DIAGNOSED WITH A KIDNEY STONE AND TREATED WITH INTRAVENOUS HYDRATION AND PAIN MEDICATIONS THAT RESULTED IN SIGNIFICANT IMPROVEMENT OF HER PAIN. SHE WAS DISCHARGED AFTER A FEW DAYS. SINCE THAT TIME, SHE HAD BEEN FEELING WEAK, TIRED, AND FATIGUED. THIS HAD SLOWLY BEEN PROGRESSING TO THE POINT WHERE SHE COULD NOT EVEN WALK 100 YARDS WITHOUT GETTING SHORT OF BREATH. THE PT COMPLAINED OF WEAK BONES AND HAD BROKEN BONES IN HER FEET TWICE IN THE LAST YEAR WITHOUT ANY MAJOR TRAUMA. THERE WAS NO CONSENSUS AS TO THE ETIOLOGY OF HER SPONTANEOUS FRACTURES. THE PT UNDERWENT A COMPREHENSIVE WORKUP, INCLUDING A BONE MARROW ASPIRATE AND BIOPSY THAT RESULTED IN A DIAGNOSIS OF BICYTOPENIAS RELATED TO COPPER DEFICIENCY FROM ZINC TOXICITY PRESUMABLY FROM THE HIGH ZINC CONTAINING DENTURE PASTE THAT SHE HAD USED FOR THE LAST SIX YEARS (SINCE 2003). THE PT WAS SUBSEQUENTLY STARTED ON COPPER REPLACEMENT THERAPY IN (B)(6) 2009 AND ADVISED TO DISCONTINUE THE USE OF THE PASTE. THE PT REPORTED AN IMPROVEMENT IN HER ENERGY LEVEL. HER BIGGEST COMPLAINT WAS RIGHT ARM AND BACK PAIN. THE PT HAD BEEN ABLE TO PERFORM HER ACTIVITIES OF DAILY LIVING WITHOUT MAJOR LIMITATION. MEDICATIONS CURRENTLY INCLUDED ZINC FREE COPPER GLUCONATE. THE PT'S COPPER LEVEL WAS 0.37, WHICH WAS SLIGHTLY BETTER BUT STILL SIGNIFICANTLY LESS THAN NORMAL. HER ZINC LEVEL WAS 1.99 MCG/ML, WHICH WAS TWICE THE UPPER LIMIT OF NORMAL. A DEXA SCAN WAS PENDING. ASSESSMENT INCLUDED ZINC OVERLOAD NEUROPATHY AND COPPER DEFICIENCY. THE PT WAS HOSPITALIZED FROM (B)(6) 2009 UNTIL (B)(6) 2009 DUE TO THE BICYTOPENIAS. OVER THE PAST SIX MONTHS, THE PT HAD SEVERE FATIGUE AND BECAME WEAKER AND DYSPNEIC AND HAD EPISODES OF TACHYCARDIA/PALPITATIONS. THE PT ALSO MENTIONED HAVING UNINTENTIONAL 40 POUND WEIGHT LOSS DURING THAT TIME, AS WELL AS FEVER AND CHILLS. DIAGNOSES ALSO INCLUDED PANCYTOPENIA. DURING HOSPITALIZATION, THE PT HAD A 15 MIN EPISODE OF APHASIA AND LEFT-SIDED FACIAL DROOP. COMPUTED TOMOGRAPHY (CT) WAS NEGATIVE. THE PT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). ON (B)(6) 2009, IT WAS NOTED THAT THE PT'S BICYTOPENIAS WERE MOST CONSISTENT WITH COPPER DEFICIENCY. ZINC LEVEL WAS 1.83 (NORMAL 0.66 TO 1.10 MCG/ML). ON (B)(6) 2009, COPPER LEVEL WAS 0.37 ( NORMAL 0.75 TO 1.45 MCG/ML) AND ZINC LEVEL WAS 1.99 (SAME NORMAL VALUES). A BONE DENSITY REPORT SHOWED OSTEOPENIA OF THE ANTERIOR/POSTERIOR (AP) LUMBAR SPINE AND TOTAL PROXIMAL FEMUR. ON (B)(6) 2009, THE PT HAD BEEN COMPLAINING OF MORE LEG WEAKNESS THAT RESULTED IN TWO FALLS WITH BILATERAL FRACTURES IN HER FEET. WITHIN THE LAST TWO WEEKS, SHE COMPLAINED OF A DULL ACHE BELOW THE LEVEL OF THE KNEE BILATERALLY. THE PT WAS DIAGNOSED WITH AN EARLY AND MILD MYELOPATHY, RELATED TO CHRONIC COPPER DEFICIENCY. NEURONTIN WAS STARTED. ON (B)(6) 2010, THE PT COMPLAINED OF CHRONIC BACK PAIN (CARES FOR AND LIFTS HUSBAND WHO WAS PARALYZED FROM THE WAIST DOWN) AND URGE INCONTINENCE. DETROL LA, LORCET, AND SOMA WERE ORDERED. ON (B)(6) 2010, COPPER WAS 0.31 AND ZINC WAS 2.20. ON (B)(6) 2010, THE PT REPORTED TO ANOTHER PHYSICIAN THAT HER COPPER LEVELS WERE NORMAL. THE PT WAS PRESCRIBED A SINGLE PRONG CANE TO MAINTAIN HER BALANCE. ON (B)(6) 2010, THE PT COMPLAINED OF NEW ONSET LEFT HIP PAIN. THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2010-00417. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE.

    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