BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE

    MDR report key: 10407776 · Received August 14, 2020

    Report

    Report Number
    3012293198-2020-00068
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 24, 2020
    Report Date
    July 24, 2020
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    I SWALLOWED A LITTLE BIT OF IT [ACCIDENTAL DEVICE INGESTION]. AND I STARTED CHOKING [CHOKING]. AND NOW I AM COUGHING A LOT. [COUGH]. REALLY COULD NOT TALK [ORAL DISCOMFORT]. NOW I AM FREAKING MYSELF OUT THINKING I HAVE COVID [SUSPECTED COVID-19]. I AM REALLY FREAKING MYSELF OUT. [ANXIETY]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 9K221C, EXPIRY DATE 20TH SEPTEMBER 2022) FOR DRY MOUTH. CONCOMITANT PRODUCTS INCLUDED GLYCERIN (BIOTENE UNKNOWN). ON (B)(6) 2020, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON (B)(6) 2020, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH, ORAL DISCOMFORT, SUSPECTED COVID-19 AND ANXIETY. BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS DISCONTINUED ON (B)(6) 2020 (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, CHOKING, COUGH, ORAL DISCOMFORT, SUSPECTED COVID-19 AND ANXIETY WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, SUSPECTED COVID-19 AND ANXIETY TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). THE REPORTER CONSIDERED THE CHOKING, COUGH AND ORAL DISCOMFORT TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ADDITIONAL INFORMATION, THE ADVERSE EVENT INFORMATION WAS RECEIVED VIA PHONE CALL ON (B)(6) 2020. CONSUMER STATED, "BIOTENE. SO I HAVE BEEN HAVING A DRY MOUTH FOR A WHILE. I USE THIS STUFF ALL TIME. I HAD IT FOR AWHILE AND I STARTED USING IT AGAIN. I SWALLOWED A LITTLE BIT OF IT AND I STARTED CHOKING AND NOW I AM COUGHING A LOT. NOW I AM FREAKING MYSELF OUT THINKING I HAVE COVID. I READ BIOTENE KEEPS YOUR SMOOTHING MOISTURIZING MAY BE I CAN CHECK. IT WILL IMMEDIATELY RELIEVE SYMPTOMS UP TO 4 HOURS. I HAVE NEVER SWALLOWED IT BEFORE. AS SOON AS I TOOK IT AND STARTED CHOKING AND I WAS COUGHING AND I REALLY COULD NOT TALK I COULD CHOKE AND COUGH. I AM REALLY FREAKING MYSELF OUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873498 BIOTENE ORIGINAL ORAL RINSE ORAL RINSES LFD KIK CUSTOM PRODUCTS 9K221C

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other