BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA

    MDR report key: 2428890 · Received January 24, 2012

    Report

    Report Number
    9681138-2012-00020
    Event Type
    Other
    Date Received
    January 24, 2012
    Date of Event
    November 10, 2011
    Report Date
    January 20, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE LOT NUMBER NOR THE PRODUCT WERE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANOSMIA IN A FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) CREAM FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED ALTERED SENSE OF SMELL SINCE (B)(6) 2011. ON (B)(6) 2011, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (UNKNOWN), UNKNOWN DOSING. SAME DAY LATER, ON (B)(6) 2011, THE PT EXPERIENCED ANOSMIA. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS CONTINUED AS THE EVENT DID NOT RESOLVED WHEN GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS NOT USED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other