BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE

    MDR report key: 13976601 · Received April 1, 2022

    Report

    Report Number
    3012293198-2022-00017
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 15, 2022
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 0

    SOMETHING FELL DOWN MY THROAT AND I COULDN'T GO TO BED [ACCIDENTAL DEVICE INGESTION]. I CHOKED IT [CHOKING]. IT BURNED MY THROAT [BURNING IN THROAT]. I EITHER COUGHED [COUGH]. 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) FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE DRY MOUTH ORAL RINSE) MOUTH WASH (BATCH NUMBER 1L213C, EXPIRY DATE 17TH OCTOBER 2024) FOR DRY MOUTH. ON (B)(6) 2022, THE PATIENT STARTED BIOTENE DRY MOUTH ORAL RINSE AT AN UNKNOWN DOSE AND FREQUENCY. ON (B)(6) 2022, AN UNKNOWN TIME AFTER STARTING BIOTENE DRY MOUTH ORAL RINSE, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BURNING IN THROAT AND COUGH. BIOTENE DRY MOUTH ORAL RINSE WAS DISCONTINUED ON (B)(6) 2022 (DECHALLENGE WAS POSITIVE). ON (B)(6) 2022, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, CHOKING, BURNING IN THROAT AND COUGH WERE RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, CHOKING, BURNING IN THROAT AND COUGH TO BE RELATED TO BIOTENE DRY MOUTH ORAL RINSE. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 15MAR2022. THE CONSUMER REPORTED THAT "THE OTHER NIGHT AS I WAS TAKING BIOTENE SOMETHING FELL DOWN MY THROAT AND I CHOKED IT BURNED MY THROAT AND I COULDN'T GO TO BED WHAT SHOULD HAVE I DONE TO STOP THE BURNING? I ATE FROZEN CHIPS FOR A FEW HOURS JUST TO GET THE BURNING TO STOP. BIOTENE DRY MOUTH ORAL RINSE. I'VE BEEN USING THIS FOR OVER AN YEAR I EITHER COUGHED OR CHOKED NO HCP HAPPENED DURING FRIDAY NIGHT I HAVEN'T USED IT SINCE 1L213C (B)(6) 2024 DRY MOUTH DURING THE NIGHT (B)(6) NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2668936 BIOTENE DRY MOUTH ORAL RINSE ORAL RINSES LFD KIK CUSTOM PRODUCTS 1L213C

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other