BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP EXTRA STRENGTH

    MDR report key: 1943507 · Received December 2, 2010

    Report

    Report Number
    9681138-2010-00401
    Event Type
    Other
    Date Received
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF NEUROPATHY IN A MALE PT WHO RECEIVED POLIGRIP EXTRA STRENGTH ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED POLIGRIP EXTRA STRENGTH (DENTAL) DAILY. AT AN UNK TIME AFTER STARTING POLIGRIP EXTRA STRENGTH, THE PT EXPERIENCED NEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. POLIGRIP EXTRA STRENGTH IS MANUFACTURED IN (B)(4) AND IS MARKETED UNDER THE TRADE NAME SUPER POLIGRIP ULTRAFRESH IN THE UNITED STATES. THE LOT NUMBER FOR THIS PRODUCT WAS NOT AVAILABLE. IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other