BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA ULTRA HAFTCREME SENSITIVE

    MDR report key: 1120679 · Received August 12, 2008

    Report

    Report Number
    9681138-2008-00013
    Event Type
    Other
    Date Received
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    GLAXOSMITHKLINE RTP
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBED THE OCCURRENCE OF ASTHMATIC ATTACK IN A FEMALE PT WHO RECEIVED COREGA HAFTCREME SENSITIVE DENTURE ADHESIVE CREAM FOR DENTURES. ON AN UNK DATE, THE PT STARTED COREGA ULTRA HAFTCREME SENSITIVE (DENTAL). AT AN UNK TIME AFTER STARTING COREGA ULTRA HAFTCREME SENSITIVE, THE PT EXPERIENCED ASTHMATIC ATTACK. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. COREGA ULTRA IS MANUFACTURED IN ANOTHER COUNTRY AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COREGA ULTRA HAFTCREME SENSITIVE DENTURE ADHESIVE KOL GLAXOSMITHKLINE RTP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other