BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2092947 · Received May 10, 2011

    Report

    Report Number
    9681138-2011-00100
    Event Type
    Other
    Date Received
    May 10, 2011
    Report Date
    May 9, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP WAS DISCONTINUED, AND IT WAS UNK IF FIXODENT WAS CONTINUED OR DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. THE PT STATED SHE WAS NOT SURE WHICH PRODUCT CAUSED THE NEUROPATHY. SUPER POLIGRIP IS MFG IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A (B)(6) FEMALE PT WHO USED AN UNK FORMULATION OF SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP AND FIXODENT. APPROX 15 YEARS PRIOR TO REPORTING, THE PT EXPERIENCED NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other