BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP ORIGINAL CREAM

    MDR report key: 1618136 · Received February 25, 2010

    Report

    Report Number
    9681138-2010-00055
    Event Type
    Other
    Date Received
    February 25, 2010
    Report Date
    February 25, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF LEUKEMIA IN A PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (DENTAL). ON (B)(6) 2009, THE PT EXPERIENCED LEUKEMIA. ON AN UNK DATE, THE PT EXPERIENCED INABILITY TO TASTE. THE CONSUMER COULD NOT PROVIDE THE LOT NUMBER AND WAS NOT RETURNING THE PRODUCT. THE CONSUMER NO LONGER HAD THE BOX AND WAS UNABLE TO READ THE LOT CODE ON THE TUBE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE IS MFG IN (B)(4) AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other