BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)

    MDR report key: 14790935 · Received June 23, 2022

    Report

    Report Number
    3012293198-2022-00029
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 14, 2022
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE ID:(B)(4).

    Description of Event or Problem · 0

    SUDDENLY SNEEZED AND SWALLOWED [ACCIDENTAL DEVICE INGESTION]. I HAVE BEEN UP ALL NIGHT COUGHING [COUGH]. I FEEL THERE IS SOMETHING IN MY THROAT [PHARYNGOLARYNX FOREIGN BODY FEELING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER OK149C, EXPIRY DATE 30TH SEPTEMBER 2023) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON (B)(6) 2022, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH AND PHARYNGOLARYNX FOREIGN BODY FEELING. THE ACTION TAKEN WITH BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, COUGH AND PHARYNGOLARYNX FOREIGN BODY FEELING WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, COUGH AND PHARYNGOLARYNX FOREIGN BODY FEELING 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 WAS RECEIVED FROM CONSUMER ON (B)(6) 2022 VIA CALL CENTER REPRESENTATIVE (PHONE). THE CONSUMER STATED THAT "LAST NIGHT I TOOK BIOTENE AND I SUDDENLY SNEEZED AND SWALLOWED. I HAVE BEEN UP ALL NIGHT COUGHING. NO. I FEEL THERE IS SOMETHING IN MY THROAT, AND I AM ALL RIGHT AND SUDDENLY IS THE URGE TO COUGH. OH, I RED THAT. SO APPARENTLY. WELL, I GOT THE BOTTLE. EXPIRY DATE IS 30SEP2023. IT IS THE ONE. YEAH DRY MOUTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455769 BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) ORAL RINSES LFD KIK CUSTOM PRODUCTS OK149C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other