BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ULTRA FRESH CREAM

    MDR report key: 1943529 · Received December 2, 2010

    Report

    Report Number
    9681138-2010-00400
    Event Type
    Other
    Date Received
    December 2, 2010
    Report Date
    December 1, 2010
    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 ULTRA FRESH DENTURE ADHESIVE CREAM FOR DENTURE ADHESION ((B)(4)). A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM, THE PT EXPERIENCED NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ULTRA FRESH CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other