BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION

    MDR report key: 11771833 · Received May 4, 2021

    Report

    Report Number
    3012293198-2021-00028
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 6, 2021
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    ALL OF A SUDDEN IT BURNED MY MOUTH / MY MOUTH BURNED / IT BURNS MY MOUTH / THE FRESH MINT BURNS MY MOUTH / JUST A LITTLE BIT BECAUSE IT BURNS MY MOUTH [BURNED MOUTH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BURNED MOUTH IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED GLYCERIN ((B)(4) DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED SODIUM FLUORIDE ((B)(4) FRESH MINT TOOTHPASTE (UNKNOWN)) TOOTHPASTE (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON (B)(6) 2021, THE PATIENT STARTED (B)(4) DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION. ON AN UNKNOWN DATE, THE PATIENT STARTED (B)(4) FRESH MINT TOOTHPASTE (UNKNOWN). ON (B)(6) 2021, AN UNKNOWN TIME AFTER STARTING (B)(4) DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION AND AN UNKNOWN TIME AFTER STARTING (B)(4) FRESH MINT TOOTHPASTE (UNKNOWN), THE PATIENT EXPERIENCED BURNED MOUTH (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). (B)(4) DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION WAS DISCONTINUED ON (B)(6) 2021 (DECHALLENGE WAS UNKNOWN). THE ACTION TAKEN WITH (B)(4) FRESH MINT TOOTHPASTE (UNKNOWN) WAS UNKNOWN. ON (B)(6) 2021, THE OUTCOME OF THE BURNED MOUTH WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BURNED MOUTH TO BE RELATED TO (B)(4) DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION AND (B)(4) FRESH MINT TOOTHPASTE (UNKNOWN). THIS REPORT IS MADE BY (B)(4) WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL CENTER REPRESENTATIVE ON (B)(6) 2021. THE CONSUMER REPORTED THAT "I HAVE USED THIS FOR YEARS AND ALL OF A SUDDEN IT BURNED MY MOUTH. DID THEY CHANGE. MY MOUTH BURNED WHEN THEY CHANGE. I KNOW THAT THE TOOTHPASTE HAS CHANGED AND I DON'T KNOW IF IT HAS THE SAME THING OR NOT". FOLLOW UP INFORMATION WAS RECEIVED ON 06 APR 2021: IT WAS NOTED THAT CASE (B)(4) SHOULD HAVE BEEN CREATED AS A FOLLOW UP FOR (B)(4) . AS PER FOLLOW UP PATIENT AGE IS UPDATED AS (B)(6) YEARS OLD, DRUG INDICATION GIVEN AS DRY MOUTH AND REPORTED DESCRIPTION ALSO UPDATED. FU2 REVISION WAS RECEIVED ON 06 APR 2021 AND NO NEW INFORMATION RECEIVED. IT CONCLUDE MERGED VERBATIM OF BOTH SOURCE DOCUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666381 BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION ORAL RINSES LFD KIK CUSTOM PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other