BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SA

    MDR report key: 2412983 · Received January 9, 2012

    Report

    Report Number
    9681138-2012-00007
    Event Type
    Other
    Date Received
    January 9, 2012
    Date of Event
    February 1, 2011
    Report Date
    January 6, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00007. NEW POLIGRIP SA IS MANUFACTURED IN (B)(4) AND MARKETED AS SUPER POLIGRIP ORIGINAL AND SUPER POLIGRIP FREE IN THE UNITED STATES. NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    HIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PSORIASIS ON THE BACK AND LOWER BODY IN A (B)(6) MALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SA/POLIGRIP FREE) FOR FIXING LOWER JAW PARTIAL DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED '7 KINDS OF MEDICINES FOR BLOOD PRESSURE'. THE PATIENT HAD NO KNOWN ALLERGIES. THE PATIENT USED 'UPPER JAW DENTURE AND LOWER JAW PARTIAL DENTURE'. 'AT (B)(6) 2011', THE PATIENT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM. APPROXIMATELY (B)(6) MONTHS LATER, 'FROM' (B)(6) 2011, THE PATIENT EXPERIENCED PSORIASIS ON HIS BACK AND LOWER BODY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS CONTINUED AND THE PATIENT ALSO USED 'OTHER COMPANY PRODUCT'. ON AN UNKNOWN DATE THE PATIENT WENT TO A DERMATOLOGIST AND PHYSICIAN. 'EACH DOCTORS DENIED THE CAUSAL RELATIONSHIP BETWEEN POLIGRIP SA AND EVENT'. AT THE TIME OF REPORTING, THE PATIENT WAS BEING TREATED FOR PSORIASIS AND THE EVENT WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW POLIGRIP SA DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other BLOOD PRESSURE MEDICATION (UNK-UNK)