BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY

    MDR report key: 14786426 · Received June 23, 2022

    Report

    Report Number
    3012293198-2022-00031
    Event Type
    Injury
    Date Received
    June 23, 2022
    Report Date
    June 17, 2022
    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 · 0

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 0

    I HAD A SERIOUS ALLERGIC RESPIRATORY REACTION,THIS EVENT ALMOST COST ME MY LIFE. [ALLERGIC RESPIRATORY DISEASE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ALLERGIC RESPIRATORY DISEASE IN A (B)(6) PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY. IN 2022, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY, THE PATIENT EXPERIENCED ALLERGIC RESPIRATORY DISEASE (SERIOUS CRITERIA LIFE THREATENING AND OTHER: SERIOUS AS PER REPORTER). BIOTENE MOISTURIZING MOUTH SPRAY WAS DISCONTINUED ON (B)(6) 2022 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ALLERGIC RESPIRATORY DISEASE WAS RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ALLERGIC RESPIRATORY DISEASE TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION RECEIVED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE (EMAIL) ON (B)(6) 2022. THE CONSUMER STATED THAT, "HELLO, I HAVE BEEN USING BIOTENE SPRAY FOR SEVERAL YEARS BUT A FEW WEEKS AGO I HAD A SERIOUS ALLERGIC RESPIRATORY REACTION. THIS EVENT ALMOST COST ME MY LIFE. FORTUNATELY, THE PHARMACY IN THE VILLAGE WHERE I WAS CARED FOR AND AFTER AN INJECTION OF, I WAS CARED FOR BY THE AMBULANCE STAFF, DURING THE TRANSPORT TO THE HOSPITAL, I HAD TO GIVE MYSELF ANOTHER INJECTION. HOWEVER, I DO NOT SEE A WARNING AGAINST THIS PRODUCT ON YOUR SITE. PLEASE TRY TO POINT ME TO WHICH PRODUCTS THAT MAKE UP THIS SPRAY COULD BE RESPONSIBLE FOR THIS INCIDENT. THANK YOU FOR REPLYING". FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2022. AS PER THE FOLLOW UP INFORMATION THE AGE, DATE OF BIRTH, INDICATION AND STOP DATE OF THE DRUG HAS BEEN UPDATED TO THE CASE. INITIAL AND FOLLOW UP HAS BEEN PROCESSED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400934 BIOTENE MOISTURIZING MOUTH SPRAY ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Life Threatening| O