BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SA

    MDR report key: 3772316 · Received March 19, 2014

    Report

    Report Number
    9681138-2014-00006
    Event Type
    Other
    Date Received
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW POLIGRIP SA (DISTRIBUTED AS SUPER POLIGRIP IN THE UNITED STATES), IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ASCITES IN A MALE PT OF UNSPECIFIED AGE WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SA) AS A DENTURE WEARER. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL). THE PT USED NEW POLIGRIP SA EVERY DAY FOR FIVE TO SIX YEARS. AT AN UNKNOWN TIME AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, ASCITES RETENTION WAS OBSERVED. DEVICE FAILURE WAS ALSO REPORTED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. ALTHOUGH THE PT WAS EXAMINED FOR THE POSSIBILITY OF CANCER IN THE DEPARTMENT OF UROLOGY AND GASTROINTESTINAL MEDICINE, THE CAUSE OF THE SYMPTOM WAS UNKNOWN. THE PT WAS INFORMED THAT NO ABNORMAL FINDINGS WERE NOTED ALSO IN THE LIVER AND KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165005 NEW POLIGRIP SA DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention