BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY

    MDR report key: 10378464 · Received August 7, 2020

    Report

    Report Number
    3012293198-2020-00063
    Event Type
    Injury
    Date Received
    August 7, 2020
    Report Date
    July 17, 2020
    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 (B)(4).

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SJOGREN'S IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY) OROMUCOSAL SPRAY (BATCH NUMBER U9N121, EXPIRY DATE 30TH NOVEMBER 2021) FOR DRY MOUTH. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE MOUTHWASH) MOUTH WASH (BATCH NUMBER U9N121, EXPIRY DATE 30TH NOVEMBER 2021) FOR DRY MOUTH AND SENSODYNE UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTHRITIS. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AT AN UNKNOWN DOSE AND FREQUENCY AND SENSODYNE UNKNOWN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AND SENSODYNE UNKNOWN, THE PATIENT EXPERIENCED SJOGREN'S (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SNEEZING, ARTHRITIS, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE MOUTHWASH WAS UNKNOWN. THE ACTION TAKEN WITH SENSODYNE UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE SJOGREN'S, SNEEZING, ARTHRITIS, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SJOGREN'S, SNEEZING AND ARTHRITIS TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AND SENSODYNE UNKNOWN. ADDITIONAL DETAILS, IT WAS VERY DIFFICULT TO OPEN FOR HER WITH HER ARTHRITIS. SHE HAD TO USE A SCISSOR TO OPEN IT. SHE WOULD LIKE TO RECOMMEND TO MAKE IT MORE EASY TO OPEN IT. SHE WOULD LIKE ALSO TO KNOW IF THERE WERE OTHER PRODUCTS WHICH SHE WOULD MOISTURE HER MOUTH SHE HAD A VERY DRY MOUTH. SHE HAD ALREADY USED A BIOTENE DRY. MOUTH SPRAY BUT IT MADE HER SNEEZING. THE CONSUMER CALLED BACK (B)(6) 2020 SHE HAD CALLED BEFORE BUT IT WAS ABOUT BIOTENE. SHE HAD SENSITIVE TEETH AND DRY MOUTH. SHE HAD USED YOUR SENSODYNE FOR HER SENSITIVE TEETH AND IT HELPED HER. AND SHE WAS USING BIOTENE DRY MOUTH MOISTURIZER MOUTHWASH SHE HAD USED THE SPRAY BUT SPRAY WAS SO SWEET. SHE HAD BEEN USING THE BIOTENE FOR HER DRY MOUTH BECAUSE SHE HAD A HEALTH CONDITION CALLED SJOGREN'S MOST OF WOMEN GET IT. IT WAS NOT A VERY POPULAR HEALTH CONDITION BUT SHE WAS DIAGNOSE WITH IT. IT WAS RECOMMEND HER TO USE BIOTENE AND SENSODYNE. SHE HAD BEEN USING IT FOR SO LONG SHE COULD EVEN REMEMBER. SHE DID NOT LIKE THE GEL BECAUSE IT TASTED SO SWEET. SHE NEVER HAD THAT ISSUE WITH THE MOUTHWASH. SHE USED A SCISSORS TO OPEN THE MOUTHWASH BECAUSE IT WAS HARD TO OPEN BECAUSE OF THE ARTHRITIS IN HER HAND. FOLLOW UP INFORMATION WAS RECEIVED ON 18 SEPTEMBER 2020 FROM DEPARTMENT OF QUALITY ASSURANCE (QA) REGARDING COMPLAINT (B)(4) (PRODUCT COMPLAINT NUMBER) FOR PRIMARY PACKAGE LOT NUMBER 0C09N1. INVESTIGATION INCLUDED BATCH RECORD REVIEW, REVIEW OF PACKAGING COMPONENTS, RETAIN EVALUATION, AND COMPLAINT TREND ANALYSIS. THIS LOT MET SPECIFICATION AT TIME OF RELEASE AND THERE WERE NO RELEVANT DEVIATIONS THAT IMPACTED THIS BATCH. CONSUMER REFUSED TO RETURN SAMPLE OR SEND PHOTO, SO WAS NOT AVAILABLE AT THE TIME OF SITE INVESTIGATION. THERE WERE NO INDICATIONS THAT THIS BATCH OF FINISHED GOODS WAS ATYPICAL WHEN IT COMES TO THE SAFETY NECKBAND AND/OR OTHER ASPECTS OF OPENING THE BOTTLE. THE LOT NUMBER 0C09N1 WAS UPDATED IN THE CASE. THIS REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS FOR THE INITIAL INFORMATION RECEIVED ON 18 SEPTEMBER 2020 AND IS AS FOLLOWS. THE PRODUCT QUALITY COMPLAINT WAS ASSOCIATED ONLY WITH BIOTENE MOUTHWASH AND NOT BIOTENE MOISTURIZING MOUTH SPRAYS. THE MEDWATCH INFORMATION WAS UPDATED FOR BIOTENE MOISTURIZING MOUTH SPRAYS AND BIOTENE MOUTHWASH.

    Additional Manufacturer Narrative · 1

    ASSOCIATED WITH ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    SJOGREN'S [SJOGREN'S]. MAKES ME SNEEZING. [SNEEZING]. ARTHRITIS IN MY HAND [ARTHRITIS]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SJOGREN'S IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY) OROMUCOSAL SPRAY (BATCH NUMBER U9N121, EXPIRY DATE 30TH NOVEMBER 2021) FOR DRY MOUTH. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE MOUTHWASH) MOUTH WASH (BATCH NUMBER U9N121, EXPIRY DATE 30TH NOVEMBER 2021) FOR DRY MOUTH AND SENSODYNE UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTHRITIS. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AT AN UNKNOWN DOSE AND FREQUENCY AND SENSODYNE UNKNOWN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AND SENSODYNE UNKNOWN, THE PATIENT EXPERIENCED SJOGREN'S (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SNEEZING, ARTHRITIS, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE MOUTHWASH WAS UNKNOWN. THE ACTION TAKEN WITH SENSODYNE UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE SJOGREN'S, SNEEZING, ARTHRITIS, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SJOGREN'S, SNEEZING AND ARTHRITIS TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY, BIOTENE MOUTHWASH AND SENSODYNE UNKNOWN. ADDITIONAL DETAILS, IT WAS VERY DIFFICULT TO OPEN FOR HER WITH HER ARTHRITIS. SHE HAD TO USE A SCISSOR TO OPEN IT. SHE WOULD LIKE TO RECOMMEND TO MAKE IT MORE EASY TO OPEN IT. SHE WOULD LIKE ALSO TO KNOW IF THERE WERE OTHER PRODUCTS WHICH SHE WOULD MOISTURE HER MOUTH SHE HAD A VERY DRY MOUTH. SHE HAD ALREADY USED A BIOTENE DRY. MOUTH SPRAY BUT IT MADE HER SNEEZING. THE CONSUMER CALLED BACK 17 JUL 2020 SHE HAD CALLED BEFORE BUT IT WAS ABOUT BIOTENE. SHE HAD SENSITIVE TEETH AND DRY MOUTH. SHE HAD USED YOUR SENSODYNE FOR HER SENSITIVE TEETH AND IT HELPED HER. AND SHE WAS USING BIOTENE DRY MOUTH MOISTURIZER MOUTHWASH SHE HAD USED THE SPRAY BUT SPRAY WAS SO SWEET. SHE HAD BEEN USING THE BIOTENE FOR HER DRY MOUTH BECAUSE SHE HAD A HEALTH CONDITION CALLED SJOGREN'S MOST OF WOMEN GET IT. IT WAS NOT A VERY POPULAR HEALTH CONDITION BUT SHE WAS DIAGNOSE WITH IT. IT WAS RECOMMEND HER TO USE BIOTENE AND SENSODYNE. SHE HAD BEEN USING IT FOR SO LONG SHE COULD EVEN REMEMBER. SHE DID NOT LIKE THE GEL BECAUSE IT TASTED SO SWEET. SHE NEVER HAD THAT ISSUE WITH THE MOUTHWASH. SHE USED A SCISSORS TO OPEN THE MOUTHWASH BECAUSE IT WAS HARD TO OPEN BECAUSE OF THE ARTHRITIS IN HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842268 BIOTENE MOISTURIZING MOUTH SPRAY ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC U9N121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other