BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ULTRA FRESH CREAM

    MDR report key: 2011798 · Received February 21, 2011

    Report

    Report Number
    9681138-2011-00048
    Event Type
    Other
    Date Received
    February 21, 2011
    Report Date
    February 18, 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). WHILE THE LOT NUMBER FOR THIS PRODUCT IS KNOWN, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LOSS OF SMELL IN A (B)(6), FEMALE, PATIENT, WHO RECEIVED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATIONS INCLUDED MOMETASONE FUROATE (NASONEX NASAL SPRAY), MULTIVITAMIN AND BOOST. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP DENTAL ADHESIVE CREAM. AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED LOSS OF SMELL, LOSS OF TASTE AND EXPIRED DRUG USED. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED THE POSSIBLE CO-SUSPECT OF NASONEX NASAL SPRAY, MULTIVITAMIN AND BOOST WHILE USING SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM. CONSUMER ISN'T SURE EXACTLY WHICH IS CAUSING HER LOSS OF SMELL AND LOSS OF TASTE. CONSUMER REPORTED MEDICATION USED PAST EXPIRY WHEN USING SUPER POLIGRIP ULTRA FRESH THAT HAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ULTRA FRESH CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE R04454

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other MOMETASONE FUROATE (NASONEX NASAL SPRAY)| BOOST| MULTIVITAMINS