BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL CREAM

    MDR report key: 1960019 · Received January 5, 2011

    Report

    Report Number
    9681138-2011-00001
    Event Type
    Other
    Date Received
    January 5, 2011
    Report Date
    January 5, 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 MFG IN (B)(4), AND THE PRODUCT WAS NOT AVAILABLE. (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 PT WHO USED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED ANOTHER UNSPECIFIED VARIANT OF SUPER POLIGRIP. ON AN UNK DATE, THE PT BEGAN USING SUPER POLIGRIP ORIGINAL AND ANOTHER SUPER POLIGRIP VARIANT. AN UNK TIME LATER, THE PT EXPERIENCED LOSS OF SMELL, STUMBLING SIDEWAYS AND FORWARD, AND LOSS OF BALANCE. SHE INDICATED THAT THIS BEGAN IN THE PAST WHEN SHE WAS USING TUBES OF SUPER POLIGRIP THAT CONTAINED ZINC. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. USE OF THE SUPER POLIGRIP PRODUCTS 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 CREAM DENTURE ADHESIVE KOL GLAXOSMITHKLINE R10333

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other