BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP DENTURE ADHESIVE POWDER

    MDR report key: 3875197 · Received June 2, 2014

    Report

    Report Number
    9681138-2014-00011
    Event Type
    Other
    Date Received
    June 2, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CANCER IN A FEMALE PATIENT WHO RECEIVED DENTURE ADHESIVE POWDER-DOUBLE SALT (SUPER POLIGRIP DENTURE ADHESIVE POWDER) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED DENTURE ADHESIVE POWDER-DOUBLE SALT (DENTAL). AT AN UNKNOWN TIME AFTER STARTING DENTURE ADHESIVE POWDER-DOUBLE SALT, THE PATIENT EXPERIENCED CANCER. THE PATIENT LEFT A VOICEMAIL AND STATED THAT SHE WAS CALLING ON SUPER POLIGRIP POWDER AND THE ADVERSE EVENT WAS CANCER. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321030 SUPER POLIGRIP DENTURE ADHESIVE POWDER DENTURE ADHESIVE POWDER-DOUBLE SALT KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other