BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA

    MDR report key: 3950789 · Received July 8, 2014

    Report

    Report Number
    9681138-2014-00012
    Event Type
    Other
    Date Received
    July 8, 2014
    Report Date
    July 4, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER DETAIL WAS PROVIDED. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2014-00012. COREGA 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, VIA NON-HCP HOSPITAL EMPLOYEE, AND DESCRIBED THE OCCURRENCE OF HOSPITALIZATION DUE TO UNKNOWN REASON IN A PATIENT WHO REC'D GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (DENTAL). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT EXPERIENCED HOSPITALIZATION DUE TO UNKNOWN REASON. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. THE REPORTED CONTACTED THE FSK CALL CENTER TO ASK ABOUT THE COREGA MARKETING AUTHORIZATION IN (B)(4) DATABASE. ACCORDING TO HER, THE PATIENT IS HOSPITALIZED (CAUSE UNKNOWN) AND THE PATIENT'S HEALTHCARE PLAN NEEDS THIS INFO TO PAY OR NOT THE SUSPECT PRODUCT TO THE PATIENT. THE REPORTER DID NOT PROVIDE ANY INFO ABOUT THE CAUSE OF HOSPITALIZATION AND DID NOT INFORM AN SYMPTOM THAT THE PATIENT PRESENTED BEFORE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398244 COREGA GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other