BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2111066 · Received May 23, 2011

    Report

    Report Number
    9681138-2011-00128
    Event Type
    Other
    Date Received
    May 23, 2011
    Report Date
    May 20, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 IS 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 TOXICITY IN A FEMALE PATIENT WHO USED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. IN 1979, THE PATIENT BEGAN USING SUPER POLIGRIP ORIGINAL, AND IN (B)(6) 2000, SHE BEGAN USING FIXODENT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING SYMPTOMS THAT INCLUDE IN LOSS OF BALANCE, TINGLING, NUMBNESS, BURNING, PAIN AND WEAKNESS IN HER FEET, LEGS, ARMS AND HANDS, FATIGUE, DIZZINESS AND UNSTEADY WALKING AND STANDING." SUPER POLIGRIP ORIGINAL AND FIXODENT WERE DISCONTINUED IN (B)(6) 2010. ACCORDING TO THE CLAIM, THE EVENTS WERE SEVERE AND PERMANENT. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2009, THE PATIENT REPORTED A STANDING HISTORY OF TENDINITIS PROBLEMS. ON (B)(6) 2010, THE PATIENT HAD SOME RECURRENT NECK, BACK, AND FOOT PAIN, BUT NOT WORSENED FROM PREVIOUS. THE PATIENT HAD A PAST MEDICAL HISTORY OF CERVICALGIA, NECK AND LEFT SHOULDER PAIN WITH TINGLING OF LEFT FINGERS, LIKELY SECONDARY TO RADICULOPATHY OF CERVICAL SPINE ((B)(6) 2005); SLIGHT TENDERNESS OF TROCHANTER AND WITH LEFT HIP MOVEMENT ((B)(6) 2005), LEFT HEEL PAIN ((B)(6) 2004), UNSPECIFIED MYALGIA AND MYOSITIS ((B)(6) 2000) AND CHRONIC PAIN SYNDROME ((B)(6) 2008). ON (B)(6) 2010, THE PATIENT'S COPPER LEVEL WAS 1.34 (NORMAL 0.75 TO 1.45 MCG/ML) AND ZINC LEVEL WAS 1.14 (NORMAL 0.66 TO 1.10 MCG/ML). FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(4) 2010, THE PATIENT REPORTED SYMPTOMS THAT SHE HAD WHICH CONCERNED HER THAT SHE MIGHT HAVE TOO MUCH COPPER OR ZINC. SHE WAS TOLD THAT SHE NEEDED ZINC AND COPPER TESTS PER HER ATTORNEY. DIAGNOSIS INCLUDED NEUROPATHY. THIS CASE WAS UPGRADED TO MEDICALLY SERIOUS BY GSK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other