BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA ADHESIVE STRIPS

    MDR report key: 6689091 · Received July 6, 2017

    Report

    Report Number
    3004699328-2017-00009
    Event Type
    Injury
    Date Received
    July 6, 2017
    Report Date
    June 26, 2017
    Manufacturer
    KYOWA, LTD.
    Product Code
    KOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH (B)(4), COREGA ADHESIVE STRIPS. COREGA ADHESIVE STRIPS ARE MARKETED IN THE US AS SUPER POLIGRIP COMFORT SEAL ADHESIVE STRIP.

    Description of Event or Problem · 1

    PROFUSE BLEEDING [HEMORRHAGE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA SALES REP AND DESCRIBED THE OCCURRENCE OF BLEEDING 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 BLEEDING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE BLEEDING WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BLEEDING TO BE RELATED TO COREGA ADHESIVE STRIPS. ADDITIONAL DETAILS, INITIAL ADVERSE EVENT REPORT WAS RECEIVED ON 26 JUN 2017 THROUGH SALES REPRESENTATIVE. THE REPORTER COMMENTED THAT A (B)(6) FEMALE PATIENT CONSUMED ANTICOAGULANTS, SHE RETIRED HER DENTAL PROSTHESIS PLACED WITH COREGA ADHESIVE AND THE PATIENT HAD A PROFUSE BLEEDING. THE ACTION TAKEN OF COREGA ADHESIVE STRIPS WAS UNKNOWN. THIS REPORT WAS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 01 JUL 2017 AND WAS AS FOLLOWS: THE DEVICE TYPE WAS CAPTURED WRONG AS DERMATOLOGICAL DEVICE WHICH WAS CHANGED TO DENTURE ADHESIVE. THIS REPORT WAS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 26 JUN 2017 AND THE INFORMATION AS FOLLOWS: THE PREVIOUS ERROR CORRECTION DATE 01 JUL 2017 (WRONG DATE REPORTED) WAS UPDATED TO 26 JUN 2017 (CORRECTED DATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470448 COREGA ADHESIVE STRIPS DENTURE ADHESIVE KOL KYOWA, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other