BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT TABLETS

    MDR report key: 2554469 · Received May 28, 2010

    Report

    Report Number
    1020379-2010-00005
    Event Type
    Other
    Date Received
    May 28, 2010
    Report Date
    May 27, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR¿S REPORT NUMBERS FOR THIS CASE ARE SUPERPOLIGRIP (9681138-2010-00204), POLIDENT TABLETS (1020379-2010-00001) AND POLIDENT TOOTHPASTE (2210777-2010-00002). SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM AND SUPER POLIGRIP ARE MANUFACTURED IN (B)(4). POLIDENT TABLETS ARE MANUFACTURED IN (B)(4) AND POLIDENT TOOTHPASTE IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP ULTRA FRESH IS AVAILABLE (LOT NUMBER X08161, EXPIRATION UNK). IT WAS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY TESTING. (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 RECEIVED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP AND POLIDENT TABLETS AND POLIDENT TOOTHPASTE. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM, THE PT EXPERIENCED NEUROPATHY. THE PT REPORTED THAT SHE EXPERIENCED NEUROPATHY FOR THREE TO FOUR YEARS AND STATED, ¿I DON¿T KNOW IF SUPER POLIGRIP CAUSED THE NEUROPATHY OR MADE IT WORSE¿ (EXACERBATION OF NEUROPATHY). SHE ALSO REPORTED THAT SHE RARELY APPLIED THE PRODUCT MORE THAN ONCE DAILY (DEVICE MISUSE). THE PT REPORTED THAT SHE USED SUPER POLIGRIP DENTURE CREAM (VARIANT NOT SPECIFIED), POLIDENT TABLETS AND POLIDENT TOOTHPASTE FOR YEARS. THE PT ALSO REPORTED THAT SHE EXPERIENCED NUMBNESS ON THE BOTTOM OF HER FEET. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT TABLETS DENTURE CARE EFT GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other POLIDENT TOOTHPASTE- (B)(4)| SUPER POLIGRIP MFR- (B)(4)