BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT)

    MDR report key: 11032444 · Received December 17, 2020

    Report

    Report Number
    3012293198-2020-00115
    Event Type
    Injury
    Date Received
    December 17, 2020
    Report Date
    December 8, 2020
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE#: (B)(4).

    Description of Event or Problem · 1

    NEARLY CHOCKED ON THIS BIOTENE, CHOKE ON MEDICATION, MADE ME SICK. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKE ON MEDICATION IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT) MOUTH WASH (BATCH NUMBER 0E21N1, EXPIRY DATE 30TH APRIL 2023) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT), THE PATIENT EXPERIENCED CHOKE ON MEDICATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SICKNESS. BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT) WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKE ON MEDICATION AND SICKNESS WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKE ON MEDICATION AND SICKNESS TO BE RELATED TO BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT). ADDITIONAL DETAILS: THE CONSUMER CHOKED ON THE BIOTENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491958 BIOTENE DRY MOUTH MOISTURIZING MOUTHWASH (FRESH MINT) ORAL RINSES LFD KIK CUSTOM PRODUCTS 0E21N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other