BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION

    MDR report key: 8170011 · Received December 17, 2018

    Report

    Report Number
    9615332-2018-00183
    Event Type
    Injury
    Date Received
    December 17, 2018
    Report Date
    December 10, 2018
    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

    MFR REPORT # 9615332-2018-00183 IS ASSOCIATED WITH ARGUS (B)(4), BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION.

    Description of Event or Problem · 1

    I WAS JUST WONDERING WHY THE LABEL SAYS NOT TO DRINK FROM THE BOTTLE WHEN YOU'RE RINSING. I'VE BEEN DOING THAT [INTENTIONAL DEVICE MISUSE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF INTENTIONAL DEVICE MISUSE IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION) MOUTH WASH FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION, THE PATIENT EXPERIENCED INTENTIONAL DEVICE MISUSE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE INTENTIONAL DEVICE MISUSE WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE INTENTIONAL DEVICE MISUSE TO BE RELATED TO BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON (B)(6) 2018. THE CONSUMER REPORTED ABOUT BIOTENE GENTLE ORAL RINSE THAT, "I WAS JUST WONDERING WHY THE LABEL SAYS NOT TO DRINK FROM THE BOTTLE WHEN YOU'RE RINSING. I'VE BEEN DOING THAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007988 BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION ORAL RINSES LFD KIK CUSTOM PRODUCTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other