BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL BALANCE GEL

    MDR report key: 17497972 · Received August 10, 2023

    Report

    Report Number
    3012293198-2023-00025
    Event Type
    Injury
    Date Received
    August 10, 2023
    Report Date
    July 13, 2023
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 0

    WE HAVE BECOME SOMEWHAT DEPENDENT ON THE PRODUCT CALLED BIOTENE [DRUG DEPENDENCE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A PHYSICIAN VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DRUG DEPENDENCE IN UN SPECIFIED NUMBER OF PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (UNKNOWN)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENTS STARTED BIOTENE MOUTH SPRAY (UNKNOWN) AND BIOTENE ORAL BALANCE GEL. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (UNKNOWN) AND BIOTENE ORAL BALANCE GEL, THE PATIENTS EXPERIENCED DRUG DEPENDENCE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), LACK OF DRUG EFFECT AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (UNKNOWN) WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE ORAL BALANCE GEL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DRUG DEPENDENCE, LACK OF DRUG EFFECT AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE DRUG DEPENDENCE TO BE RELATED TO BIOTENE MOUTH SPRAY (UNKNOWN). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DRUG DEPENDENCE TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA CALL CENTER REPRESENTATIVE (PHONE) ON (B)(6) 2023. CONSUMER REPORTED THAT " DOES CONSUMER GIVES CONSENT FOR FOLLOW UP : NO WE HAVE BECOME SOMEWHAT DEPENDENT ON THE PRODUCT CALLED BIOTENE. OVER THE LAST SIX WEEKS. WE HAVE BEEN TRYING TO GET BIOTENE PRODUCTS, AND NONE OF THE PHARMACIES APPEAR TO HAVE . CAN YOU ASSIST ME IN THAT REGARD, PLEASE. IT IS A SPRAY IN PARTICULAR. IT IS THE SPRAY AND THE MOUTH WASH . THE GEL IS NOT VERY EFFECTIVE UNFORTUNATELY .IT TENDS TO DRY UP IN THE MOUTH BUT I MEAN THAT IS A PRACTICALITY BETWEEN DIFFERENT PATIENTS. WE HAVEN'T SEEN IT AND ALL THE PHARMACIES THERE MAYBE AN OCCASIONAL BOTTLE. IT JUST SUPPLIES VERY DISAPPOINTING. IT IS SUCH AN EXCELLENT PRODUCT. WHAT IS BEEN CAUSING THE WAY THEY ARE EXTRAORDINARY TODAY. THE REASON I AM CALLING THE DRY MOUTH MOISTURIZING BALANCE TENDS TO GEL ACTUALLY ALMOST DO THE OPPOSITION MAKE IT STICKS TO THE TEETH OR STICKS TO THE GUMS . IM SORRY. I MEAN, IF YOU CAN NOT SUPPLY THE HE THING. AS A DOCTOR WITH PATIENTS SUFFERING FROM THIS . IM TERRIBLY DISAPPOINTED. IM NOT PLAYING HERE ON BLAMING THE FACT THAT THE BEST IN ALTERNATIVE AND IT IS SO THE POPULARITY AND THE ONE ID BIG DEMAND IS SUCH CAN NOT IMAGINE THAT THE COMPANY WOULD RUN OUT. OBVIOUSLY YOU CAN NOT HELP . I WILL SKIP IT. THANK YOU. IN THE MEANTIME, THE PATIENTS STUFF IT IS NOT YOUR FAULT. IF YOU DO NOT HAVE THE SUPPLY. YOU DO NOT KNOW THAT IS THE END. BUT TO BE THE HELP PURPOSE OF MY INQUIRIES. THANK . YOU. I AM SORRY. I AM LOOKING FOR A PRODUCT AND YOU ARE TELLING ME THAT YOU DO NOT HAVE IT AND YOU CAN NOT SUPPLIES FOR SOME TIME. TO GO INTO THE ISSUE WITH IT IS AN ABSOLUTE WASTE OF TIME AND THE FACT THAT NOBODY ELSE IS BOTHERING TO MANUFACTURE ANYTHING. IS IS EQUALLY BAD. UM, AS AS PRACTICED IN TRYING TO ASSIST PEOPLE WHO IN PURGATORY WITH THE FACT THAT THEY ARE NOT MAKING SALIVA. I REALLY DO NOT WANT TO GO INTO A DISCUSSION. I HAVE TRIED TO SEE IF, UM, ONE OF THE COMPANIES IN AUSTRALIA CAN HELP AND EVERYBODY WANTS TO ASK QUESTIONS, BUT NOBODY WANTS TO SUPPLY THE GOOD". FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM QUALITY ASSURANCE (QA) DEPARTMENT REGARDING PRODUCT QUALITY COMPLAINT WITH CASE NUMBER (B)(4) FOR UNKNOWN LOT NUMBER. INVESTIGATION EVALUATION: NO SAMPLE WAS RETURNED FOR THIS COMPLAINT AND THE LOT/BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION CANNOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED AND WILL BE CLOSED AS INCONCLUSIVE. IF THE CONSUMER CONTACTS US WITH ADDITIONAL INFORMATION OR IF THE COMPLAINT SAMPLE IS RECEIVED, THE COMPLAINT ISSUE WILL BE REOPENED AND FURTHER EVALUATED. RESPONSE TO CONSUMER (IF APPLICABLE): NO SAMPLE WAS RETURNED FOR THIS COMPLAINT, ALSO BATCH DETAILS WERE NOT RECEIVED SO A FULL INVESTIGATION COULD NOT BE COMPLETED. AS THIS INFORMATION IS NOT AVAILABLE THE COMPLAINT CANNOT BE SUBSTANTIATED. ALL OF THE DOCUMENTATION PERTINENT TO A SPECIFIC LOT OF FINISHED PRODUCT IS CONTAINED IN A BATCH ENVELOPE'. PRIOR TO THE DISPOSITION OF THE PRODUCT, THE CONTENTS OF EACH BATCH ENVELOPE IS REVIEWED & APPROVED BY THE SITE QUALITY DEPARTMENT TO VERIFY THAT THERE WERE NO SIGNIFICANT QUALITY ISSUES RECORDED DURING MANUFACTURING, PACKAGING OR TESTING. THIS REVIEW ALSO VERIFIES THAT ALL TEST RESULTS MEET SPECIFICATION REQUIREMENTS. COMPLAINT CONCLUSION: COMPLAINT INCONCLUSIVE. PRODUCT COMPLAINT ID REPORTED AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063439 BIOTENE ORAL BALANCE GEL ORAL GEL LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other