BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2213981 · Received August 1, 2011

    Report

    Report Number
    9681138-2011-00188
    Event Type
    Other
    Date Received
    August 1, 2011
    Report Date
    July 29, 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 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 TOXICITY IN A FEMALE PT 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 1996, THE PT BEGAN USING SUPER POLIGRIP ORIGINAL AND FIXODENT. ON AN UNK DATE, THE PT EXPERIENCED ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN SYMPTOMS THAT INCLUDE NUMBNESS, TINGLING, BURNING, PAIN AND WEAKNESS IN HER HANDS, NUMBNESS AND BURNING IN HER FEET, DIZZINESS AND DIFFICULTY WALKING. USE OF SUPER POLIGRIP ORIGINAL AND FIXODENT WERE CONTINUED. ACCORDING TO THE CLAIM, THE EVENTS WERE PROFOUND AND PERMANENT. F/U INFO WAS REC'D ON (B)(4) 2011, VIA MEDICAL RECORDS. ON (B)(6) 2011, THE PT REQUESTED ZINC AND COPPER TESTING DUE TO COMPLAINTS OF NUMBNESS AND TINGLING IN HANDS/FINGERS/FEET. THE PT HAD NEUROPATHY AND HAS HAD SHINGLES FOR SIX YRS. ASSESSMENT INCLUDED MODERATE ACUTE NEUROPATHY AND CHRONIC POSTTHERAPEUTIC POLYNEUROPATHY. ON (B)(6) 2011, THE PT'S ZINC LEVEL WAS 1.65 (NORMAL 0.66 TO 1.10) AND THE COPPER LEVEL WAS 0.96 (NORMAL 0.75 TO 1.45). THIS CASE HAS BEEN 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