BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)

    MDR report key: 10845170 · Received November 16, 2020

    Report

    Report Number
    3012293198-2020-00104
    Event Type
    Injury
    Date Received
    November 16, 2020
    Report Date
    November 3, 2020
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    I JUST TOOK 1 TABLESPOON OF THE BIOTENE DRY MOUTH ORAL RINSE, SOMEHOW WHEN I SWISH IT, I CHOKED [CHOKING]. AND SWALLOWED IT. [ACCIDENTAL DEVICE INGESTION] I NEVER USED IT 5 TIMES A DAY. I WILL ONLY USE IT 3 TIMES A DAY [DEVICE USED FOR UNAPPROVED SCHEDULE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 9A003C, EXPIRY DATE 17TH DECEMBER 2021) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND DEVICE USED FOR UNAPPROVED SCHEDULE. THE ACTION TAKEN WITH BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL DEVICE INGESTION AND DEVICE USED FOR UNAPPROVED SCHEDULE WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND DEVICE USED FOR UNAPPROVED SCHEDULE TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION RECEIVED VIA CALL CENTER REPRESENTATIVE ON 3 NOVEMBER 2020. THE CONSUMER REPORTED, "I JUST TOOK 1 TABLESPOON OF THE BIOTENE DRY MOUTH ORAL RINSE, SOMEHOW WHEN I SWISH IT, I CHOKED AND SWALLOWED IT. IS THERE ANYTHING SPECIAL THAT I SHOULD DO. I DRANK 16OZ OF WATER TO DILUTE IT. I USED IT PROBABLY FOR 6 MONTHS, I NEVER ACCIDENTALLY SWALLOWED IT BEFORE. I USED IT ABOUT 20 MINUTES AGO. I HAVE EXTREMELY DRY MOUTH, SOMETIMES I TRY TO LIMIT IT. I NEVER USED IT 5 TIMES A DAY. I WILL ONLY USE IT 3 TIMES A DAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313252 BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) ORAL RINSES LFD KIK CUSTOM PRODUCTS 9A003C

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other