BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP COMFORT SEAL STRIPS

    MDR report key: 6490362 · Received April 13, 2017

    Report

    Report Number
    3004699328-2017-00003
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    April 6, 2017
    Manufacturer
    KYOWA, LTD.
    Product Code
    KOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), SUPER POLIGRIP COMFORT SEAL STRIPS.

    Description of Event or Problem · 1

    THE GLUE AND WENT DOWN MY THROAT AND CHOKED ME [ACCIDENTAL DEVICE INGESTION], THE GLUE AND WENT DOWN MY THROAT AND CHOKED ME [CHOKING], DISPLEASED WITH THIS PRODUCT SAYS ALL DAYS STRONG AND IN STEAD IT CAME UNDONE [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP COMFORT SEAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP COMFORT SEAL STRIPS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, CHOKING AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, CHOKING AND PRODUCT COMPLAINT TO BE RELATED TO SUPER POLIGRIP COMFORT SEAL STRIPS. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL ON 6 APRIL 2017. CONSUMER REPORTED USING SUPER POLIGRIP STRIPS, NO LOT CODE WAS PROVIDED. CONSUMER REPORTED THE GLUE WENT DOWN HIS THROAT AND CHOKED HIM. CONSUMER ALSO REPORTED THAT THIS PRODUCT SAID ALL DAYS STRONG AND IN STEAD IT CAME UNDONE. THE ACTION TAKEN WITH SUPER POLIGRIP COMFORT SEAL STRIPS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273170 SUPER POLIGRIP COMFORT SEAL STRIPS DENTURE ADHESIVE KOL KYOWA, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other