BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 1812536 · Received August 16, 2010

    Report

    Report Number
    9681138-2010-00296
    Event Type
    Other
    Date Received
    August 16, 2010
    Report Date
    August 16, 2010
    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 DENTURE ADHESIVE POWDER IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE (LOT NUMBER N09494). IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ORAL CANCER IN AN (B)(+) FEMALE PT WHO RECEIVED SUPER POLIGRIP DENTURE ADHESIVE POWDER (B)(4) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP DENTURE ADHESIVE POWDER (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP DENTURE ADHESIVE POWDER, THE PT EXPERIENCED ORAL CANCER, GINGIVAL CANCER, GUM SORENESS AND GINGIVAL BLEEDING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). TREATMENT WITH SUPER POLIGRIP DENTURE ADHESIVE POWDER WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE CONSUMER REPORTS USING THE SUPER POLIGRIP POWDER FOR YEARS WHEN ORAL CANCER WAS DIAGNOSED. SHE REC'D 34 RADIATION TREATMENTS AND WAS PRONOUNCED CANCER FREE. SHE STOPPED USING THE SUPER POLIGRIP WHILE IN RADIATION AND FOR ONE WEEK FOLLOWING TREATMENTS. SHE RESUMED USE OF SUPER POLIGRIP POWDER AND REPORTS HER LOWER GUM IS SORE AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP DENTURE ADHESIVE POWDER KOL GLAXOSMITHKLINE N09494

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other