BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION

    MDR report key: 10362152 · Received August 4, 2020

    Report

    Report Number
    3012293198-2020-00057
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 7, 2020
    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 · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    I WAS SWISHING FOR ABOUT 30 SECONDS AND I ACCIDENTLY SWALLOWED IT ABOUT [ACCIDENTAL DEVICE INGESTION]. I HAD CATARACT SURGERY YESTERDAY [CATARACT OPERATION]. I AM A BIT WOOZY I THINK I FEEL WEIRD FROM THAT [FEELING ABNORMAL]. 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 DRY MOUTH ORAL RINSE FRESH MINT SOLUTION) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION. ON (B)(6) 2020, SEVERAL DAYS AFTER STARTING BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION, THE PATIENT EXPERIENCED CATARACT OPERATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON (B)(6) 2020, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FEELING ABNORMAL. THE ACTION TAKEN WITH BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION WAS UNKNOWN. ON (B)(6) 2020, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS RECOVERED/RESOLVED. ON AN UNKNOWN DATE, THE OUTCOME OF THE CATARACT OPERATION AND FEELING ABNORMAL WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND CATARACT OPERATION TO BE RELATED TO BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION. THE REPORTER CONSIDERED THE FEELING ABNORMAL TO BE RELATED TO BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION, THE ADVERSE EVENT INFORMATION WAS RECEIVED VIA PHONE CALL ON (B)(6) 2020. CONSUMER STATED, "BIOTENE DRY MOUTH ORAL RINSE. I JUST SWALLOWED A TABLESPOON OF IT IS THAT HARMFUL? THE FRESH MINT RINSE. I HAVE BEEN USING IT FOR A FEW WEEKS. I WAS SWISHING FOR ABOUT 30 SECONDS AND I ACCIDENTLY SWALLOWED IT ABOUT. I HAVEN'T HAD ANY ISSUES BUT I HAD CATARACT SURGERY YESTERDAY SO I AM A BIT WOOZY I THINK I FEEL WEIRD FROM THAT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825077 BIOTENE DRY MOUTH ORAL RINSE FRESH MINT SOLUTION ORAL RINSES LFD KIK CUSTOM PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other