BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP CREAM

    MDR report key: 1512844 · Received April 27, 2009

    Report

    Report Number
    9681138-2009-00063
    Event Type
    Other
    Date Received
    April 27, 2009
    Report Date
    April 27, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA FDA MEDWATCH PROGRAM (B)(4) AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A PT WHO RECEIVED SUPER POLIGRIP DENTURE ADHESIVE CREAM (FORMULATION UNK) FOR DENTURE ADHESION. CO-SUSPECT MEDICATION INCLUDED FIXODENT AND SEA BOND DENTURE ADHESIVE. IN 1999, THE PT STARTED USING SUPER POLIGRIP (DENTAL), FIXODENT (DENTAL) AND SEA BOND (DENTAL) DAILY. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, FIXODENT AND SEA BOND, THE PT EXPERIENCED NUMBNESS AND TINGLING OF EXTREMITIES. THE PT WAS DIAGNOSED WITH NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE REGULATORY AUTHORITY CONSIDERED THE EVENTS TO BE DISABLING. THE PT WAS TOLD THAT THEY HAD BEEN EXPOSED TO SOME SORT OF TOXIN THAT CAUSED NERVE DAMAGE IN LEGS. SUPER POLIGRIP, FIXODENT AND SEA BOND WERE DISCONTINUED. AT THE TIME OF REPORTING THE EVENTS WERE UNRESOLVED. THE MANUFACTURER REPORT NUMBER FOR THIS CASE IS 9681138-2009-00063. SUPER POLIGRIP IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S FIXODENT| SEA BOND DENTURE ADHESIVE