BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE CREAM

    MDR report key: 1912834 · Received November 8, 2010

    Report

    Report Number
    9681138-2010-00381
    Event Type
    Other
    Date Received
    November 8, 2010
    Report Date
    November 8, 2010
    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 FEMALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE REPORTED AS IN THE LATE 1970S, THE PT STARTED SUPER POLIGRIP. IN 2004, AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT WAS DIAGNOSED WITH NEUROPATHY. THE PT EXPERIENCED DEVICE MISUSE BY APPLYING SUPER POLIGRIP THREE TIMES A DAY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1