BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY

    MDR report key: 11920659 · Received June 2, 2021

    Report

    Report Number
    3012293198-2021-00037
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    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 ID: (B)(4).

    Description of Event or Problem · 1

    I SEIZURE AFTER I USE IT [SEIZURE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SEIZURE IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY) OROMUCOSAL SPRAY FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED BIOTENE UNKNOWN CUTANEOUS LIQUID (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY AT AN UNKNOWN DOSE AND FREQUENCY AND BIOTENE UNKNOWN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY AND BIOTENE UNKNOWN, THE PATIENT EXPERIENCED SEIZURE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND UNEXPECTED THERAPEUTIC EFFECT. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE SEIZURE AND UNEXPECTED THERAPEUTIC EFFECT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SEIZURE TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY AND BIOTENE UNKNOWN. 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 CASE WAS REPORTED BY CONSUMER VIA CALL CENTER REPRESENTATIVE ON 12 MAY 2021. THE CONSUMER STATED THAT "HOW ARE YOU DOING TODAY? THE FLAVORS ARE BOTHERING ME, BUT I AM SO HAPPY I FOUND YOUR PRODUCTS! THEY HAVE HELPED ME TO STRENGTHEN MY TEETH AND BIOTENE PRODUCTS LIKE YOUR MOUTHWASH I USED TO USE, IT HAD BEEN TOO MINTY, SPLENDA I MAY BE ALLERGIC TO. YOUR SPRAY IS GREAT BUT TOO STRONG!!!!! I SEIZURE AFTER I USE IT. SO PLEASE CHANGE YOUR BIOTENE FLAVORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817469 BIOTENE MOISTURIZING MOUTH SPRAY ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other