BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP FREE DENTURE CREAM

    MDR report key: 1799474 · Received August 6, 2010

    Report

    Report Number
    9681138-2010-00287
    Event Type
    Other
    Date Received
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTC PRODUCT: YES.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF VISION WORSENED IN A (B)(6) FEMALE PT WHO USED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM AS A DENTURE ADHESIVE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT BEGAN USING SUPER POLIGRIP FREE. AN UNK TIME LATER, THE PT EXPERIENCED VISION WORSENED, LEG NUMBNESS, LEG PAIN AND PRODUCT COMPLAINT OF THE PRODUCT STICKING TO HER GUMS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. USE OF SUPER POLIGRIP FREE WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WERE UNRESOLVED. THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2010-00287. SUPER POLIGRIP FREE IS MFG IN (B)(4), AND THE PRODUCT WAS NOT AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP FREE DENTURE CREAM DENTURE ADHESIVE KOL GLAXOSMITHKLINE X08061 OR V08061

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other