BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (VARIANT UNKNOWN)

    MDR report key: 1914456 · Received November 22, 2010

    Report

    Report Number
    9681138-2010-00397
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    November 22, 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

    CONSUMER REPORTED THAT HE HAS BEEN USING SUPER POLIGRIP ALL DIFFERENT VARIANTS AND FIXODENT FOR APPROX 27 YEARS. CONSUMER REPORTED HE WAS FIRST TOLD THAT HE SUFFERED WITH MORTON'S NEUROMA. CONSUMER REPORTED THAT APPROX 14 TO 15 YEARS AGO HE WENT TO A NEUROLOGIST AND WAS TOLD HE HAS NEUROPATHY IN HIS FEET. CONSUMER SAYS HE CAN DROP A HAMMER ON HIS FEET AND NOT FEEL IT. SUPER POLIGRIP IS MFG IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER WERE AVAILABLE. (B)(4).

    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 CREAM (FORMULATION UNK) OVER A PERIOD OF 27 YEARS FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED FIXODENT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP CREAM (DENTAL). THE PT REPORTED THAT HE SOMETIMES APPLIED THE PRODUCT MORE THAN ONCE DAILY (DEVICE MISUSE). ON AN UNK DATE, THE PT WAS DIAGNOSED WITH MORTON'S NEUROMA. HE REPORTED THAT APPROX 14 OR 15 YEARS AGO, HE WAS DIAGNOSED WITH NEUROPATHY IN HIS FEET. HE STATED THAT HE COULD DROP A HAMMER ON HIS FEET AND NOT FEEL IT. THE PT ALSO REPORTED THAT HE EXPERIENCED SEVERE NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP CREAM 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 (VARIANT UNKNOWN) DENTURE ADHESIVE KOL GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT