BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (FREE AND EXTRA CARE)

    MDR report key: 1914306 · Received November 12, 2010

    Report

    Report Number
    9681138-2010-00388
    Event Type
    Other
    Date Received
    November 12, 2010
    Report Date
    November 12, 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 FREE DENTURE ADHESIVE CREAM AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL ARE MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCTS NOR LOT NUMBERS ARE AVAILABLE. (B)(4). ADDITIONAL LOT # & EXPIRATION DATE: UNK.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A MALE PT WHO RECEIVED SUPER POLIGRIP FREE DENTURE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED BAD VISION OF EYE. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP EXTRA CARE WITH POLISEAL ((B)(4)). ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP FREE DENTURE CREAM (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP FREE DENTURE CREAM, THE PT EXPERIENCED LEG NUMBNESS AND OCCASIONAL LOSS OF BALANCE. THE PT REPORTED THAT APPROX FOUR OR FIVE MONTHS AGO, HE WAS DIAGNOSED WITH NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP FREE DENTURE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT OF OCCASIONAL LOSS OF BALANCE WAS RESOLVED. THE EVENTS OF NEUROPATHY AND NUMBNESS IN LEGS WERE UNRESOLVED. CONSUMER REPORTED THAT HE WAS DIAGNOSED WITH NEUROPATHY FOUR OR FIVE MONTHS AGO AND HAS NUMBNESS IN HIS LEGS AND LOSES HIS BALANCE OCCASIONALLY. THE EVENT OF NEUROPATHY AND NUMBNESS IN HIS LEGS IS NOT RESOLVED. THE EVENT OF LOSES HIS BALANCE IS CURRENTLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FREE AND EXTRA CARE) DENTURE ADHESIVES KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other