BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA

    MDR report key: 2343967 · Received November 15, 2011

    Report

    Report Number
    9681138-2011-00249
    Event Type
    Other
    Date Received
    November 15, 2011
    Date of Event
    November 8, 2011
    Report Date
    November 15, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COREGA IS MANUFACTURED IN (B)(4), AND MARKETED AS SUPER POLIGRIP IN THE UNITED STATES. THE PRODUCT WAS NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF WHITE MUCUS IN A (B)(6) OLD FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (COREGA DENTURE ADHESIVE CREAM) CREAM OVER A PERIOD OF 1 DAY FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON (B)(6) 2011, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK) (DENTAL). APPROX 1 HOUR LATER, ON (B)(6) 2011, THE PT EXPERIENCED WHITE MUCUS IN MOUTH AND CALLED AN AMBULANCE. THE DOCTORS DETECTED PAROXYSMAL ATRIAL FIBRILLATION AND HYPERTENSION AGGRAVATED. THE PT WAS TREATED WITH PROCAINAMIDE AND FOR THE NEXT FEW DAYS EXPERIENCED WEAKNESS AND DIZZINESS. TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNK) WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE IMPROVED. THE REPORTER CONSIDERED THAT THE EVENTS WERE POSSIBLY RELATED TO TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COREGA GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA R09365

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention