BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER COREGA POWDER

    MDR report key: 3354916 · Received September 10, 2013

    Report

    Report Number
    9681138-2013-00028
    Event Type
    Other
    Date Received
    September 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    September 9, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING PHARMACIST CONSIDERED THE EVENTS WERE PROBABLY RELATED TO TREATMENT WITH DENTURE ADHESIVE POWDER-CMC OR DOUBLE SALT. THE PHARMACIST RECEIVED THE REPORT VIA THE DAUGHTER OF THE PT. THE REPORT WAS INITIALLY RECEIVED BY THE QUALITY ASSURANCE DEPARTMENT AT GSK. FOLLOW-UP WAS RECEIVED ON 09/06/2013. THE PHARMACIST PROVIDED THE PT'S INITIALS AND REPORTED THAT SHE WAS (B)(6) YEARS OF AGE. THE PT WAS A FREQUENT USER OF COREGA CREAM AND HAD NOT EXPERIENCED ANY ADVERSE EVENT OR ALLERGIC REACTION. THIS WAS THE PT'S FIRST TIME USING SUPER COREGA POWDER. SUPER COREGA POWDER (DISTRIBUTED AS SUPER POLIGRIP POWDER IN THE UNITED STATES), IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBED THE OCCURRENCE OF HYPERSENSITIVITY IN A FEMALE PT WHO RECEIVED DENTURE ADHESIVE POWDER-CMC OR DOUBLE SALT (SUPER COREGA POWDER) POWDER FOR DENTURE ADHESION. CONCURRENT CONDITIONS INCLUDE DENTURE WEARER. IN 2013 THE PT STARTED DENTURE ADHESIVE POWDER-CMC OR DOUBLE SALT. IN 2013, THE PT EXPERIENCED HYPERSENSITIVITY, SWELLING OF TONGUE, TONGUE BROWN AND RESPIRATORY DIFFICULTY. THE PHARMACIST LODGED A PRODUCT COMPLAINT. THE PHARMACIST CONSIDERED THE EVENTS TO BE CLINICALLY SIGNIFICANT (OR REQUIRING INTERVENTION). THE PT PRESENTED TO A MEDICAL CENTER AND WAS TREATED WITH SYSTEMIC CORTICOSTEROIDS. THE PT WAS INSTRUCTED TO TAKE A FIVE DAY COURSE OF ORAL CORTICOSTEROIDS. IT WAS NOT REPORTED WHETHER THE PT WAS ADMITTED FROM THE EMERGENCY ROOM. TREATMENT WITH DENTURE ADHESIVE POWDER-CMC OR DOUBLE SALT WAS DISCONTINUED. AT THE TIME OF REPORTING, THE BROWN TONGUE HAD IMPROVED AS IT HAD ALMOST RETURNED TO ITS NORMAL COLOR WHILE THE TONGUE SWELLING AND RESPIRATORY DIFFICULTY HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453833 SUPER COREGA POWDER DENTURE ADHESIVE POWDER-CMC OR DOUBLE SALT KOL GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention LUTEIN| GARLIC| ZINC