BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2101152 · Received May 16, 2011

    Report

    Report Number
    9681138-2011-00114
    Event Type
    Other
    Date Received
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 REC'D SUPER POLIGRIP (UNK FORMULATION) OVER A PERIOD OF 30 YEARS FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DENTAL IMPLANT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED NEUROPATHY, NUMBNESS AND TINGLING. THE PT REPORTED THAT HER ZINC AND COPPER LEVELS WERE NORMAL. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    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 79 YR Other