BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA ULTRA CREAM

    MDR report key: 3020652 · Received March 21, 2013

    Report

    Report Number
    9681138-2013-00004
    Event Type
    Other
    Date Received
    March 21, 2013
    Report Date
    March 19, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-0004. COREGA ULTRA CREAM IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF INTOXICATION IN A FEMALE PT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (COREGA ULTRA CREAM) CREAM FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSION HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED "FOOD OR MEDICATION" (UNKNOWN). ON AN UNK DATE, THE PT STARTED TRIPLE SALT DENTAL ADHESIVE CREAM (DENTAL). IMMEDIATE AFTER STARTING TRIPLE SALT DENTAL ADHESIVE CREAM, THE PT EXPERIENCED FACIAL ALLERGY WHICH WAS DIAGNOSED AS INTOXICATION CAUSED BY FOODS OR MEDICATIONS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119018 COREGA ULTRA CREAM TRIPLE SALT DENTAL ADHESIVE CREAM KOO GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other