BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SG/SA

    MDR report key: 2412984 · Received January 9, 2012

    Report

    Report Number
    9681138-2012-00006
    Event Type
    Other
    Date Received
    January 9, 2012
    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 9681138-2012-00006. NEW POLIGRIP SG/SA IS MANUFACTURED IN (B)(4), AND MARKETED AS SUPER POLIGRIP ORIGINAL AND SUPER POLIGRIP FREE IN THE UNITED STATES. NEITHER THE LOT NUMBERS NOR THE PRODUCTS WERE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ABDOMINAL DISTENSION IN A MALE PATIENT OF UNSPECIFIED AGE WHO USED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SA) CREAM FOR PARTIAL DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED NEW POLIGRIP SG. ON AN UNKNOWN DATE APPROXIMATELY 10 YEARS AGO, THE PATIENT STARTED USING DOUBLE SALT DENTAL ADHESIVE CREAM (DENTAL) - BOTH NEW POLIGRIP SA AND NEW POLIGRIP SG. APPROXIMATELY FIVE YEARS AFTER STARTING USE WITH DOUBLE SALT DENTAL ADHESIVE CREAM, THE PATIENT EXPERIENCED 'ABDOMINAL ENLARGED' AND WAS HOSPITALIZED FOR A MONTH. ON AN UNKNOWN DATE, THE PATIENT 'BEGAN TO SUFFER FROM DISORDER OF KNEE JOINT AS A FALLOUT' THOUGH HE HAD ALREADY LEFT THE HOSPITAL. THE 'PRIMARY DOCTOR' SAID THE CAUSE OF THE 'KNEE JOINT' WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT 'DIDN'T TALK ABOUT POLIGRIP USE TO THE PRIMARY DOCTOR'. IN ADDITION THE PATIENT USED EXCESSIVE AMOUNTS OF POLIGRIP AND ASKED 'WHAT WILL HAPPEN IF I USE 40G TUBE OF POLIGRIP PER DAY'. 'APPROXIMATELY TWO YEARS AGO', TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING THE PATIENT WAS A DENTURE WEARER, BUT NOT PARTIAL DENTURES. AT THE TIME OF REPORTING, THE OUTCOME OF THE ABDOMINAL DISTENTION WAS RESOLVED AND THE OUTCOME OF THE ARTHROPATHY WAS UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization