BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL

    MDR report key: 1971868 · Received January 17, 2011

    Report

    Report Number
    9681138-2011-00016
    Event Type
    Other
    Date Received
    January 17, 2011
    Report Date
    January 13, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 NEUROPATHY IN A PT WHO USED SUPER POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATIONS INCLUDED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM ((B)(4)) AND FIXODENT. IN 2004, THE PT USED SUPER POLIGRIP AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP, THE PT EXPERIENCED NEUROPATHY, ZINC TOXICITY, AND NERVE DAMAGE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. ACCORDING TO THE LEGAL COMPLAINT, THE PT EXPERIENCED "ZINC TOXICITY AND EXTENSIVE NERVE DAMAGE THAT RESULTED IN SYMPTOMS THAT INCLUDE BURNING, NUMBNESS AND TINGLING IN UPPER AND LOWER EXTREMITIES AND PERIPHERAL NEUROPATHY". THE PT "SUFFERED SEVERE AND PERMANENT PHYSICAL INJURIES, INCLUDING BUT NOT LIMITED TO PROFOUND AND PERMANENT NEUROLOGICAL INJURIES." IT WAS FURTHER REPORTED THE PATIENT'S "INJURIES AND DAMAGES ARE PERMANENT AND WILL CONTINUE INTO THE FUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP/SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAMS KOL GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT