BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP COMFORT SEAL STRIPS

    MDR report key: 9558752 · Received January 7, 2020

    Report

    Report Number
    3004699328-2019-00023
    Event Type
    Injury
    Date Received
    January 7, 2020
    Report Date
    December 9, 2019
    Manufacturer
    KYOWA LTD IZUMISANO FACTORY
    Product Code
    KOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    I COULDN'T USE THEM BEFORE BECAUSE I WOULD CHOKE ON THEM. [CHOKING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) FEMALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP FOR DENTURE WEARER. CO-SUSPECT PRODUCTS INCLUDED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)) CREAM FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP COMFORT SEAL STRIPS AND SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP COMFORT SEAL STRIPS AND SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND GAGGING. THE ACTION TAKEN WITH SUPER POLIGRIP COMFORT SEAL STRIPS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND GAGGING WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO SUPER POLIGRIP COMFORT SEAL STRIPS. THE REPORTER CONSIDERED THE GAGGING TO BE RELATED TO SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON 09 DECEMBER 2019. THE CONSUMER REPORTED THAT "SUPER POLGIRIP STRIPS, I BOUGHT THEM TO PUT IT ON MY BOTTOM PARTIALS AND THEY DID PRETTY WELL WHEN I EAT. THEY WERE OUT OF MY MOUTH IN THE MORNING. DID THEY DISSOLVE OR WHAT? I TRIED SOME OTHER PRODUCT OF POLIGRIP AND IT MADE ME GAG. WOULD PUT SOMEONE ON THE PHONE THAT SPEAKS ENGLISH? I BROUGHT THESE POLIGRIP STRIPS, FOR MY LOWER DENTURES AND I TRIED THEM BEFORE FOR THE UPPER. I COULDN'T USE THEM BEFORE BECAUSE I WOULD CHOKE ON THEM. SO I USED THEM FOR THE BOTTOM AND WHEN I WOKE UP THIS MORNING IT WOULD BE GONE. ARE THEY DISSOLVING OR WHAT? I WANT TO UNDERSTAND IF IT'S SUPPOSE TO DISSOLVE OR AM I SWALLOWING THEM. THIS WAS YEARS AGO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20817 SUPER POLIGRIP COMFORT SEAL STRIPS DENTURE ADHESIVE KOL KYOWA LTD IZUMISANO FACTORY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other