BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA ADHESIVE STRIPS

    MDR report key: 8707711 · Received June 18, 2019

    Report

    Report Number
    3004699328-2019-00009
    Event Type
    Injury
    Date Received
    June 18, 2019
    Report Date
    June 6, 2019
    Manufacturer
    KYOWA LTD IZUMISANO FACTORY
    Product Code
    KOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    ANEURYSM [ANEURYSM], MESENTERIC ISCHEMIA [MESENTERIC ISCHEMIA]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA SALES REP AND DESCRIBED THE OCCURRENCE OF ANEURYSM IN A (B)(6) FEMALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (COREGA ADHESIVE STRIPS) STRIP FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA ADHESIVE STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA ADHESIVE STRIPS, THE PATIENT EXPERIENCED ANEURYSM AND MESENTERIC ISCHEMIA (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ANEURYSM AND MESENTERIC ISCHEMIA WERE UNKNOWN. THE REPORTER CONSIDERED THE ANEURYSM AND MESENTERIC ISCHEMIA TO BE RELATED TO COREGA ADHESIVE STRIPS. ADDITIONAL DETAILS: THE DENTIST REPORTED THAT THE PATIENT SUFFERED FROM ANEURYSM AND MESENTERIC ISCHEMIA AND BELIEVED THAT IT WAS RELATED TO THE USE OF ADHESIVE COREGA. THE ACTION TAKEN WITH COREGA ADHESIVE STRIPS WAS WITHDRAWN. DECHALLENGE WAS UNKNOWN. THIS CASE WAS LINKED WITH CASE ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503029 COREGA ADHESIVE STRIPS DENTURE ADHESIVE KOL KYOWA LTD IZUMISANO FACTORY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other