BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (FORMULATION UNKNOWN)

    MDR report key: 1435506 · Received March 24, 2009

    Report

    Report Number
    9681138-2009-00034
    Event Type
    Other
    Date Received
    March 24, 2009
    Report Date
    March 24, 2009
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A REGULATORY AUTHORITY (MEDWATCH PROGRAM) AND DESCRIBED THE OCCURRENCE OF TINGLING IN UPPER EXTREMITIES IN A FEMALE PT WHO RECEIVED SUPER POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. CO-SUSPECT MEDICATION INCLUDED SEA BOND DENTURE ADHESIVE. IN 1997, THE PT STARTED SUPER POLIGRIP (DENTAL) AND SEA BOND DENTURE ADHESIVE. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED TINGLING AND NUMBNESS IN UPPER EXTREMITIES. THE PT WAS DIAGNOSED WITH NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE REGULATORY AUTHORITY REPORTED THAT THE EVENTS WERE DISABLING. TREATMENT WITH SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2009-00034 AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (FORMULATION UNKNOWN) DENTURE ADHESIVE CREAM KOL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability SEABOND DENTURE ADHESIVE