BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP AND SUPER POLIGRIP

    MDR report key: 1353715 · Received March 18, 2009

    Report

    Report Number
    9681138-2009-00026
    Event Type
    Other
    Date Received
    March 18, 2009
    Report Date
    March 16, 2009
    Manufacturer
    GLAXOSMITH KLINE RTP
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A REGULATORY AUTHORITY (MEDWATCH PROGRAM) AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A MALE PATIENT WHO RECEIVED POLIGRIP FOR DENTURES. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP, FIXODENT AND SEA BOND. IN 1979 THE PATIENT STARTED POLIGRIP (DENTAL) AND SUPERPOLIGRIP (DENTAL). AT AN UNK TIME AFTER STARTING POLIGRIP AND SUPER POLIGRIP, THE PATIENT EXPERIENCED NUMBNESS IN LEG AND FOOT, TINGLING LEG AND FEET, LOSS OF SENSATION LOWER LEG, AND BONE MARROW PROBLEMS (UNSPECIFIED). THE PT STATED THAT HE HAD BEEN DIAGNOSED WITH NEUROPATHY, ANEMIA, NEUTROPENIA AND VASCULAR DISEASE. THE PATIENT STATED THAT HE IS PERMANENTLY DISABLED DUE TO THESE CONDITIONS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNRESOLVED. POLIGRIP IS MANUFACTURED IN ANOTHER COUNTRY, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP AND SUPER POLIGRIP DENTURE ADHESIVE KOL GLAXOSMITH KLINE RTP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FIXODENT| SEA BOND