BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER POLIGRIP COMFORT SEAL STRIPS

    MDR report key: 7289124 · Received February 22, 2018

    Report

    Report Number
    3004699328-2018-00002
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    February 16, 2018
    Manufacturer
    KYOWA LTD IZUMISANO FACTORY
    Product Code
    KOL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH (B)(4), SUPER POLIGRIP COMFORT SEAL STRIPS (LOT 57056XC).

    Description of Event or Problem · 1

    PATIENT SWALLOWED THE WHOLE STRIP [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP (BATCH NUMBER 57056XC, EXPIRY DATE UNKNOWN) FOR DENTURE FAILURE. CO-SUSPECT PRODUCTS INCLUDED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP (BATCH NUMBER 15K0106, EXPIRY DATE UNKNOWN) FOR DENTURE FAILURE. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED SUPER POLIGRIP COMFORT SEAL STRIPS AND SUPER POLIGRIP COMFORT SEAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING SUPER POLIGRIP COMFORT SEAL STRIPS AND SUPER POLIGRIP COMFORT SEAL STRIPS, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO SUPER POLIGRIP COMFORT SEAL STRIPS AND SUPER POLIGRIP COMFORT SEAL STRIPS. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA PHONE CALL ON 16 FEBRUARY 2018. THE CONSUMER REPORTED THAT THE PATIENT SWALLOWED THE WHOLE STRIP. PRIMARY PACKAGE LOT NUMBER WAS 57056XC AND SECONDARY PACKAGE LOT NUMBER WAS 15K0106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133437 SUPER POLIGRIP COMFORT SEAL STRIPS DENTURE ADHESIVE KOL KYOWA LTD IZUMISANO FACTORY 57056XC

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other