BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP DENTURE ADHESIVE CREAM

    MDR report key: 1474680 · Received September 15, 2009

    Report

    Report Number
    9681138-2009-00143
    Event Type
    Other
    Date Received
    September 15, 2009
    Report Date
    September 14, 2009
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF MUCOUS MEMBRANE BLEEDING IN A FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (COREGA EXTRA STRONG) CREAM FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED GSK DENTURE ADHESIVE. AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE, THE PT EXPERIENCED BLEEDING AND BURNING OF MUCOUS MEMBRANE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GSK DENTURE ADHESIVE WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. THE PT CONSIDERED THE EVENTS WERE POSSIBLY RELATED TO TREATMENT WITH GSK DENTURE ADHESIVE. COREGA IS MARKETED IN THE UNITED STATES AS SUPER POLIGRIP. SUPER POLIGRIP IS MFG IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other