BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ULTRA FRESH

    MDR report key: 1761193 · Received July 14, 2010

    Report

    Report Number
    9681138-2010-00259
    Event Type
    Other
    Date Received
    July 14, 2010
    Report Date
    July 14, 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

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF MYELONEUROPATHY IN A (B)(6), MALE, PT, WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (POLIGRIP EXTRA STRENGTH) OVER A PERIOD OF 35 YEARS FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DIABETES, FOOD ALLERGY-MONOSODIUM GLUTAMATE-HIVES, HIGH CHOLESTEROL , AND HYPERTENSION. CONCURRENT MEDICATIONS INCLUDED ANTIHYPERTENSIVE (ANTI-HYPERTENSIVE). ON AN UNK DATE, THE PT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM (DENTAL). ON (B)(6) 2010, THE PT EXPERIENCED MYELONEUROPATHY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE DOSE OF TRIPLE SALT DENTAL ADHESIVE CREAM WAS REDUCED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. POLIGRIP EXTRA STRENGTH (MARKETED AS SUPER POLIGRIP ULTRA FRESH IN THE US) IS MFG IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS KNOWN; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QA TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE KOL GLAXOSMITHKLINE X09071A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ANTI-HYPERTENSIVE