BEUDAMED
    FDA Adverse Event Summary report: N

    COREGA CREAM

    MDR report key: 1200466 · Received October 1, 2008

    Report

    Report Number
    9681138-2008-00015
    Date Received
    October 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COREGA CREAM IS MANUFACTURED IN OTHER COUNTRY, AND NEITHER THE PRODUCT NOR LOT NUMBER OF THIS PRODUCT IS AVAILABLE.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF GASTRITIS IN AN ELDERLY MALE PATIENT WHO RECEIVED COREGA CREAM FOR FITTING OF DENTURE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED POOR HEARING. IN 2008, THE PATIENT STARTED COREGA (DENTAL). IN THE FOLLOWING MONTH, AFTER THE START OF A SECOND TUBE OF COREGA, THE PATIENT EXPERIENCED ELEVATED BLOOD PRESSURE, RISE IN TEMPERATURE (37.6), VOMITING AND DIARRHEA. THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUID(S) (INTRAVENOUS FLUIDS). GASTRITIS WAS DIAGNOSED. THE PATIENT IMPROVED IN THE SECOND DAY FOLLOWING HOSPITALIZATION AND WAS DISCHARGED AFTER 2 WEEKS. THE EMERGENCY ASSISTANT CONSIDERED THAT THE EVENTS WERE RELATED TO COREGA. DETAILS OF EXAMINATIONS ARE UNKNOWN. TREATMENT WITH COREGA WAS DISCONTINUED AND THE EVENTS WERE RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFO RECEIVED 26 SEPTEMBER 2008 FROM CITY'S CHIEF DENTIST: THE CHIEF DENTIST CONTACTED EMERGENCY AND TOLD THAT THERE WAS NOT A RELATIONSHIP BETWEEN THE EVENTS AND COREGA. THE PATIENT WROTE A LETTER TO A NEWSPAPER TO REQUEST INFO ABOUT COREGA'S ANALYSIS AND COMPOSITION. THE CHIEF DENTIST WROTE THE REPLY TO THE NEWSPAPER ABOUT COMPOSITION OF THE COREGA AND ABSENCE OF INFO IN THE LITERATURE ABOUT SIMILAR CASES DURING COREGA USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization