BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2467789 · Received February 21, 2012

    Report

    Report Number
    9681138-2012-00030
    Event Type
    Other
    Date Received
    February 21, 2012
    Report Date
    February 20, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00030. SUPER POLIGRIP IS MANUFACTURED 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 LAWYER VIA A LEGAL CLAIM AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A FEMALE PT WHO USED SUPER POLIGRIP AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED FIXODENT. THE PT USED SUPER POLIGRIP FROM 1983 TO 2003 AND FIXODENT FROM 2000 TO 2011. ON AN UNK DATE, THE PT EXPERIENCED NEUROPATHY AND NERVE DAMAGE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. SUPER POLIGRIP WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other