BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    MDR report key: 2163584 · Received June 9, 2011

    Report

    Report Number
    9681138-2011-00143
    Event Type
    Other
    Date Received
    June 9, 2011
    Report Date
    June 8, 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 ORIGINAL 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 BACK FRACTURE IN A MALE 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 1987, THE PATIENT BEGAN USING SUPER POLIGRIP ORIGINAL AND FIXODENT. AN UNKNOWN TIME LATER, THE PATIENT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE RESULTING IN DAMAGES THAT INCLUDE TINGLING, NUMBNESS, WEAKNESS AND SPASMS IN HIS ARMS, HANDS, LEGS AND FEET, DIFFICULTY WALKING AND LOSS OF COORDINATION NECESSITATES THE USE OF A CANE AND WALKER, AND MULTIPLE FALLS THAT CAUSED HIM TO BREAK HIS BACK TWICE/" THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. SUPER POLIGRIP ORIGINAL AND FIXODENT WERE DISCONTINUED IN 2010. ACCORDING TO THE CLAIM, THE EVENTS WERE PROFOUND AND PERMANENT.

    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