BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2011775 · Received February 21, 2011

    Report

    Report Number
    9681138-2011-00047
    Event Type
    Other
    Date Received
    February 21, 2011
    Report Date
    February 17, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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 DAMAGE IN A FEMALE PATIENT WHO USED SUPER POLIGRIP (FORMULATION UNKNOWN) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT USED SUPER POLIGRIP AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING POLIGRIP, THE PATIENT EXPERIENCED NERVE DAMAGE AND PERSONAL INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. MEDICAL RECORDS RECEIVED (B)(6) 2011: ON (B)(6) 2010, THE (B)(6) PATIENT WAS SEEN BY A HEMATOLOGIST FOR NEWLY DIAGNOSED MICROCYTIC ANEMIA AND FATIGUE OVER THE YEAR PRIOR. HEMOGLOBIN WAS 9.3, HEMATOCRIT WAS 30.3, AND MEAN CORPUSCULAR VOLUME WAS 72. SHE WAS STARTED ON IRON AND GIVEN A DOSE OF VENOFER. AT FOLLOW UP ON (B)(6) 2010, IT WAS NOTED THE PATIENT'S COPPER LEVEL CAME BACK PROFOUNDLY LOW AT 2 WITH AN ELEVATED ZINC LEVEL AT 195. SHE HAD BEEN USING A ZINC-CONTAINING DENTURE CREAM, WHICH HAD BEEN DISCONTINUED. SHE ALSO NOTED SOME SIGNIFICANT MUSCLE WEAKNESS AND SOME NEUROPATHY-TYPE SYMPTOMS. THE HEMATOLOGIST FELT THE ANEMIA AND NEUROPATHY SYMPTOMS WERE DUE TO THE COPPER DEFICIENCY "PROBABLY PRECIPITATED BY HER HIGH ZINC CONTENT IN DENTURE CREAM." THE PATIENT AS TAKING COPPER SUPPLEMENTS, AND HER BLOOD COUNT HAD IMPROVED. AT FOLLOW UP ON (B)(6) 2010, SHE CONTINUED TO HAVE SIGNIFICANT FATIGUE, NEUROPATHY, AND WEAKNESS SYMPTOMS WITH NO IMPROVEMENT. SHE CONTINUED TO REQUIRE USE OF A WALKER. HER BLOOD COUNTS CONTINUED TO IMPROVE AT THAT TIME. ON (B)(6) 2010, THE PATIENT WAS SEEN BY A NEUROLOGIST FOR NUMBNESS THAT BEGAN NINE MONTHS PRIOR. THE ONSET WAS GRADUAL, AND SHE DESCRIBED THE NUMBNESS AS A TINGLING SENSATION AND DECREASED SENSATION. THIS BEGAN WITH THE HANDS AND SPREAD TO THE FEET AND UP TO THE HIPS WITHIN SEVERAL WEEKS. THE PATIENT ALSO HAD WEAKNESS, AND ALL THIS CAUSED DIFFICULTY WITH GAIT AND WALKING. SHE COULD NOT OPEN BOTTLES, LIFT NORMAL OBJECTS WITHOUT DROPPING THEM, CLIMB STAIRS, OR GET INTO/OUT OF A BATHTUB ALONE, AND THE PATIENT HAD EXPERIENCED SEVERAL FALLS. BRAIN CT WAS NORMAL, BUT LAB WORK REVEALED ZINC TOXICITY AND COPPER DEFICIENCY "LIKELY FROM DENTURE CREAM USE FOR 19 YEARS NOW." SHE WAS DIAGNOSED WITH NEUROPATHY FROM ZINC TOXICITY AT THIS TIME. AT HEMATOLOGY FOLLOW UP ON (B)(6) 2011, THE PATIENT'S ANEMIA WAS MUCH IMPROVED, BUT SHE CONTINUED TO HAVE NEUROPATHY SYMPTOMS. THIS CASE WAS NOW CONSIDERED MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other