BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2163666 · Received June 13, 2011

    Report

    Report Number
    9681138-2011-00145
    Event Type
    Other
    Date Received
    June 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PT WHO RECEIVED SUPER POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO ZINC AND IODINE ALLERGY. CO-SUSPECT MEDICATION INCLUDED FIXODENT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP THE PT EXPERIENCED NEUROPATHY, POLYNEUROPATHY, WHEELCHAIR USER, INABILITY TO WALK, ARM NUMBNESS, METAL POISONING, UNABLE TO FEEL FEET AND GAGGING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THIS CONSUMER REPORTS HAVING NEUROPATHY, POLYNEUROPATHY, BEING UNABLE TO WALK SO HAVING TO BE IN A WHEELCHAIR, ZINC POISONING AND COPPER POISONING (METAL POISONING), ARM NUMBNESS, BEING UNABLE TO FEEL HER FEET AND THAT SHE USED TO GAG EVERY TIME THAT SHE USED SUPER POLIGRIP. THIS CONSUMER REPORTED USING BOTH SUPER POLIGRIP AND FIXODENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other