BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL DENTURE CREAM

    MDR report key: 1423871 · Received July 27, 2009

    Report

    Report Number
    9681138-2009-00125
    Event Type
    Other
    Date Received
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REPORT NUMBER FOR THIS CASE IS 9681138-2009-000125. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DECREASED WHITE BLOOD CELL COUNT IN A (B)(6) FEMALE PATIENT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM, FORMULATION (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. PATIENT REPORTED A HISTORY OF APLASTIC ANEMIA ((B)(6) 2009) , CANCER OF BONE MARROW ((B)(6) 2009), AND A TRANSFUSION OF 22 UNITS OF BLOOD SINCE (B)(6) 2009 TO THE TIME OF THIS REPORT. PATIENT HAS VISITED THE EMERGENCY ROOM SEVERAL TIMES FROM (B)(6) 2008 TO (B)(6) 2009. ON AN UNKNOWN DATE APPROXIMATELY THREE YEARS PRIOR TO REPORTING, THE PATIENT STARTED SUPER POLIGRIP. AT AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP, THE PATIENT EXPERIENCED DECREASED WHITE BLOOD CELL COUNT WITH A RESULT OF "0 MG/ML" [SIC], LOSS OF ENERGY, LOCAL SWELLING DESCRIBED AS A BUMP IN HER MOUTH, SORE THROAT AND GENERAL BODY PAIN. THE PATIENT WAS HOSPITALISED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. CONSUMER HAS BEEN HOSPITALIZED SEVERAL TIMES FOR BLOOD TRANSFUSIONS OF A TOTAL OF 22 UNITS FROM (B)(6) 2009 TO THE TIME OF THIS REPORT. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM KOL GLAXOSMITHKLINE R09074

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization