BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2163623 · Received June 8, 2011

    Report

    Report Number
    9681138-2011-00136
    Event Type
    Other
    Date Received
    June 8, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF ZINC POISONING IN A MALE PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING SUPER POLIGRIP. AN UNK TIME LATER, THE PT EXPERIENCED ZINC POISONING AND NERVE INJURY. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. MED RECORDS RECEIVED (B)(4) 2010: ON (B)(6) 2003, THE (B)(6) OLD PT WAS SEEN BY A NEUROLOGIST WITH BILATERAL LOWER EXTREMITY WEAKNESS (RIGHT WORSE THAN LEFT), LOSING BALANCE, AND DIFFICULTY WALKING TO THE POINT OF REQUIRING A CANE. THESE SYMPTOMS BEGAN TWO YEARS PRIOR, AND BRAIN MRI HAD SHOWN ATROPHY IN THE FRONTAL PARIETAL REGION WITHOUT ANY SIGNIFICANT FINDINGS. ON (B)(6) 2009, HIS COPPER LEVEL WAS MEASURED AT 60 MCG/L (NORMAL 700 TO 1750), AND ZINC WAS 1772 MCG/L (NORMAL 600 TO 1200). FOLLOW UP INFO WAS RECEIVED ON (B)(6) 2011 VIA FACT SHEETS. THE PT RECEIVED DISABILITY FROM 2006 UNTIL 2010 FOR AN UNK INDICATION. THE PT PERMANENTLY USED A CANE AND A BATTERY-OPERATED SCOOTER AS A RESULT OF HIS POLIGRIP USE. IN 2001, THE PT EXPERIENCED BILATERAL LOWER LEG WEAKNESS. THE PT WAS DIAGNOSED WITH SEVERE BILATERAL LOWER POLYNEUROPATHY IN (B)(6) 2009. EARLIER IN 2009, THE PT WAS FOUND TO HAVE ELEVATED ZINC AND DEPRESSED COPPER LEVELS. THE PT WAS ALSO DIAGNOSED WITH ANEMIA. THE PT FIRST USED UPPER AND LOWER DENTURES IN 1987. THE PT USED SUPER POLIGRIP FROM 1994 TO THE TIME OF THIS REPORT, AT LEAST TWICE DAILY, ONE HALF TO THREE FOURTHS 2.4 OUNCE TUBES. THIS CASE WAS UPGRADED TO 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