BEUDAMED
    FDA Adverse Event Other Summary report: N

    COREGA

    MDR report key: 3190964 · Received June 21, 2013

    Report

    Report Number
    9681138-2013-00015
    Event Type
    Other
    Date Received
    June 21, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA A LEGAL COMPLAINT AND DESCRIBED THE OCCURRENCE OF VISION LOSS IN A (B)(6) FEMALE PATIENT WHO USED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (COREGA). 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 EXPERIENCED VISION LOSS, SCALY SKIN, HAIR LOSS, LIP SWELLING, BRUISING OF LEG, LUMPS ON BODY AND MUSCLE PAIN. SHE ALSO REPORTED NASAL DRUG EXPULSION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2013-00015. 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
    282314 COREGA GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other