BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SG/SA

    MDR report key: 2249593 · Received August 17, 2011

    Report

    Report Number
    9681138-2011-00201
    Event Type
    Other
    Date Received
    August 17, 2011
    Report Date
    August 16, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# B1183. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BLOOD AMYLASE INCREASED IN A (B)(6) MALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SG) CREAM FOR DENTURE WEARER. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED NEW POLIGRIP SA. CONCURRENT MEDICATIONS INCLUDED BLOOD PRESSURE MEDICATION. ON AN UNK DATE, ONE YEAR AGO, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL), UNK DOSING AND NEW POLIGRIP SA (B)(6)MONTHS AGO. THE PT USED 5 MM OF CREAM AT THREE POINTS ON THE DENTURE. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM AND NEW POLIGRIP SA, THE PT EXPERIENCED BLOOD AMYLASE INCREASED (TWICE AS HIGH AS THE RESULT LAST YEAR). THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2011-00201. NEW POLIGRIP SA/SG IS MANUFACTURED IN (B)(4) AND MARKED UNDER THE TRADE NAME SUPER POLIGRIP IN THE UNITED STATES. THE PRODUCTS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW POLIGRIP SG/SA DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA IBO754

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other BLOOD PRESSURE MEDICATION - UNK