BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT DENTU GEL TOOTHPASTE

    MDR report key: 1914439 · Received November 22, 2010

    Report

    Report Number
    2210777-2010-00003
    Event Type
    Other
    Date Received
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (PT'S DAUGHTER) AND DESCRIBED THE OCCURRENCE OF POSSIBLE STROKE IN A (B)(6) YEAR-OLD FEMALE PT WHO RECEIVED POLIDENT DENTU GEL TOOTHPASTE FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED POLIDENT DENTU GEL TOOTHPASTE (DENTAL). AT AN UNK TIME AFTER STARTING POLIDENT DENTU GEL TOOTHPASTE, THE PT EXPERIENCED POSSIBLE STROKE, MOUTH SWOLLEN, SLURRED SPEECH, SLOW SPEECH, LIP SWELLING, ALLERGIC REACTION AND SPEECH DIFFICULTY. THE REPORTER STATED, "I DON'T KNOW IF THE SLURRED SPEECH IS BECAUSE OF HER MOTH SWOLLEN OR IF IT WAS A STROKE". CONSUMER'S DAUGHTER REPORTS THAT HER MOTHER USED THE PRODUCT IN HER MOUTH (DEVICE MISUSE). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. POLIDENT DENTU GEL TOOTHPASTE IS MFG IN CLIFTON, NJ AND NEITHER THE PRODUCT NOR LOT NUMBER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT DENTU GEL TOOTHPASTE DENTURE CLEANSER EFT GLAXOSMITHKLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR