BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREGA

    MDR report key: 3281977 · Received August 2, 2013

    Report

    Report Number
    9681138-2013-00025
    Event Type
    Death
    Date Received
    August 2, 2013
    Report Date
    August 5, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM AND DESCRIBED THE OCCURRENCE OF DEATH (NOS) IN A FEMALE PATIENT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA) FOR AN UNKNOWN INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT BEGAN USING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PATIENT DIED FROM AN UNSPECIFIED CAUSE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED, AND THE REPORTER REFUSED TO BE CONTACTED TO PROVIDE ADDITIONAL INFORMATION. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00025. COREGA IS MANUFACTURED IN (B)(4), AND MARKETED AS SUPER POLIGRIP IN THE UNITED STATES. NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363990 COREGA GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death