BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 1981229 · Received January 28, 2011

    Report

    Report Number
    9681138-2011-00025
    Event Type
    Other
    Date Received
    January 28, 2011
    Report Date
    January 27, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A LAWYER AND DESCRIBED THE OCCURRENCE OF COPPER DEFICIENCY 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 COPPER DEFICIENCY, ZINC POISONING, AND NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. ACCORDING TO A LEGAL CLAIM, THERE WERE 26 PATIENTS WHO REPORTED BEING REGULAR USERS OF ZINC-CONTAINING POLIGRIP OR A COMBINATION OF ZINC-CONTAINING POLIGRIP AND FIXODENT. ALL OF THE PATIENT'S EXPERIENCED "NEUROLOGICAL MANIFESTATIONS OF ZINC-INDUCED COPPER DEFICIENCY." THE ATTORNEYS BELIEVED THAT THEIR "CLIENTS' USE OF POLIGRIP WAS THE SUBSTANTIAL AND PROVABLE CAUSE OF THEIR INJURIES." MEDICAL RECORDS RECEIVED (B)(6) 2010: ON (B)(6) 2006, THE PT WAS NOTED TO HAVE A COLD SENSATION IN BOTH HANDS AND FEET. THIS HAD BEEN WORKED UP THOROUGHLY BY PAST PHYSICIANS WITH NO DOCUMENTATION. AT A VISIT ON (B)(6) 2008, IT WAS NOTED THE PT HAD GRADUAL ONSET ANEMIA THAT WAS BEING TREATED WITH FOLIC ACID. THIS WAS IMPROVED AT FOLLOW UP ON (B)(6) 2008 AND THE PT HAD CUT DOWN ON HIS ETHANOL USAGE. ON (B)(6) 2008, THE PT WAS HOSPITALIZED WITH NAUSEA, VOMITING, AND DIARRHEA. HE WAS FOUND TO HAVE METABOLIC ACIDOSIS AND SOME HYPOKALEMIA AS WELL AS SIGNIFICANT DECUBITUS ULCERS. THE PT WAS PLACED ON ZINC AND VITAMIN C, AND HE WAS NOTED TO BE THROMBOCYTOPENIC AS WELL. HE WAS DISCHARGED ON (B)(6) 2008, TO A NURSING HOME. ON (B)(6) 2009, THE PT NOTED WEIGHT GAIN AND PERSISTENT BILATERAL LEG WEAKNESS, WITH LEFT WORSE THAN THE RIGHT ASSOCIATED TO A "CHRONIC NEUROPATHY". THE PT REQUESTED BLOOD TESTING ON THE RECOMMENDATION OF HIS LAWYER TO SEE IF THERE WAS A CAUSTIC RELATIONSHIP BETWEEN NEUROPATHY AND EXPOSURE TO SOME HEAVY METALS. AT A VISIT ON (B)(6) 2010, IT WAS NOTED THAT PT HAD BEEN IN A WHEELCHAIR SINCE (B)(6) 2004 DUE TO LEG WEAKNESS AND LOSS OF SENSATION. HE HAD BEEN USING POLIGRIP CREAM FOR DENTURES SINCE 1998. THE NEUROLOGIST FELT THE PATIENT'S PERIPHERAL NEUROPATHY WAS MOST LIKELY DUE TO EXPOSURE TO ZINC, WITH PAST ALCOHOL DRINKING AS A CONTRIBUTING FACTOR. FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2011 VIA MEDICAL RECORDS. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS. ON (B)(6)1999, THE PT REPORTED SEVERAL MONTHS OF LEFT CALF CLAUDICATION. THE PT WA UNABLE TO WALK 300 YEARS AND FOUND THAT THIS WAS SOMEWHAT LIMITING AS IT OCCURRED SEVERAL TIMES PER DAY WITHIN HIS WORK SITUATION. HE ALSO COMPLAINED OF NUMBNESS OF THE TOES OF HIS LEFT FOOT, WHICH BEGAN ALSO MONTHS AGO. THE PT HAD A HISTORY OF RIGHT KNEE SURGERY IN 1966 AND 1968. IN THE PAST, PRIOR TO HIS CLAUDICATION SYMPTOMS, HIS ABILITY TO WALK LONG DISTANCES WAS LIMITED BY BILATERAL KNEE PAIN. THE PT DRANK FIVE TO SIX DRINKS PER DAY. IMPRESSION INCLUDED LEFT CALF CLAUDICATION SECONDARY TO ARTERIAL INSUFFICIENCY. ON (B)(6) 2003, THE PT COMPLAINED OF ATAXIA AND NUMBNESS IN BOTH FEET. THIS BEGAN AS NUMBNESS IN HIS LEFT FOOT ABOUT TWO TO THREE YEARS AGO (SINCE APPROX 2000 OR 2001). HE WAS EVALUATED AT THAT TIME FOR VASCULAR CLAUDICATION AND THE WORK UP WAS NEGATIVE. ABOUT ONE YEAR LATER (IN 2001 OR 2002), HE NOTICED SIMILAR SYMPTOMS IN HIS RIGHT FOOT. HIS LEGS HAVE FELT WEAK AND HIS BALANCE HAD BEEN POOR FOR ABOUT ONE AND ONE-HALF YEARS. HE DROVE A CAR, BUT COULD NOT FEEL THE PEDALS. THE NUMBNESS HAD PROGRESSED OVER THE PAST THREE WEEKS FROM HIS LEGS UP HIS THIGHS AND TO HIS ABDOMEN, TO INCLUDE HIS GENITALS. HE HAD BEEN UNABLE TO ACHIEVE ERECTIONS FOR A FEW WEEKS. DIAGNOSIS INCLUDED PERIPHERAL NEUROPATHY, WHICH WAS CONFIRMED BY ELECTROMYOGRAPHY (EMG) AND CLASSIFIED AS A SENSORIMOTOR AXONAL NEUROPATHY. IT WAS SUSPECTED THAT CHRONIC ALCOHOL USE MIGHT BE THE ETIOLOGY. HE ALSO HAD A SENSORY LEVEL ON HIS TRUNK AND RELATIVELY RAPIDLY PROGRESSING SYMPTOMS WHICH WAS UNUSUAL FOR AN ALCOHOLIC PERIPHERAL NEUROPATHY. THE PT WAS HOSPITALIZED FROM (B)(6) 2006 WITH, ALTERED MENTAL STATUS AND GENERALIZED WEAKNESS. IMPRESSION INCLUDED NEUROPATHY RELATED TO ALCOHOL AND POSSIBLE COMBINED DEGENERATION OF THE CORD.

    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 64 YR Hospitalization