BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP/SUPER POLIGRIP

    MDR report key: 1552387 · Received September 17, 2009

    Report

    Report Number
    9681138-2009-00148
    Event Type
    Other
    Date Received
    September 17, 2009
    Report Date
    September 17, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2009-00148. POLIGRIP/SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCTS NOR LOT NUMBERS FOR WERE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED VIA THE FDA MEDWATCH PROGRAM (B)(4) AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A PT, WHO USED SUPER POLIGRIP (FORMULATION UNK) AS A DENTURE ADHESIVE. CO-SUSPECT PRODUCTS INCLUDED POLIGRIP AND FIXODENT. THE PT USED FIXODENT FROM 1980 TO 2004, POLIGRIP FROM 2004 TO 2006, AND SUPER POLIGRIP FROM 2006 TO THE PRESENT. IN 2002, THE PT WAS DIAGNOSED WITH A HEART ARRHYTHMIA AND PROVIDED WITH A PACEMAKER. THIS REQUIRED CONTINUING MEDICAL MONITORING AND PERIODIC SURGICAL REPLACEMENT. ON AN UNK DATE, THE PT BEGAN TO EXPERIENCE SOME NUMBNESS AND LACK OF REFLEX IN THE FEET AND KNEES. THIS PROGRESSED UNTIL HE/SHE BEGAN TO HAVE TROUBLE WALKING AND MAINTAINING BALANCE. THE PT FELL SEVERAL TIMES REQUIRING EMERGENCY MEDICAL TREATMENT. IN 2008, THE PT DIAGNOSED WITH SEVERE NEUROPATHY AND STATED THIS WAS PERMANENT AND REQUIRED CONTINUING MEDICAL TREATMENT. THE EVENTS PREVENTED THE PT FROM PERFORMING PRIOR ACTIVITIES, INCLUDING BICYCLE/MOTORCYCLE RIDING, HIKING, AND AIRPLANE PILOTING. THE REGULATORY AUTHORITY REPORTED THAT THE EVENTS WERE DISABLING. USE OF SUPER POLIGRIP WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability