BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)

    MDR report key: 17681472 · Received September 5, 2023

    Report

    Report Number
    3012293198-2023-00029
    Event Type
    Injury
    Date Received
    September 5, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 0

    I CHOKED REAL REAL BAD. I STILL HAVE A COUGH NOW FROM THE BIOTENE THAT CHOKED ME AND ITS STILL IN MY THROAT. [CHOKE ON MEDICATION]. I STILL HAVE A COUGH NOW FROM THE BIOTENE THAT ITS STILL IN MY THROAT, I KEPT COUGHING AND COUGHING, I STILL HAVE A COUGH BUT NOT AS BAD. [COUGH]. I COULDN'T EVEN GOT MY BREATH, I CHOKED SO BAD [BREATHLESSNESS]. I SPRAYED MY MOUTH WITH THAT THING WHEN YOU HAVE A SORE THROAT AND NOTHING HELPED ME [DEVICE USE IN UNAPPROVED INDICATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKE ON MEDICATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR SORE THROAT AND DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED CHOKE ON MEDICATION (SERIOUS CRITERIA HALEON MEDICALLY SIGNIFICANT), COUGH, BREATHLESSNESS AND DEVICE USE IN UNAPPROVED INDICATION. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKE ON MEDICATION, BREATHLESSNESS AND DEVICE USE IN UNAPPROVED INDICATION WERE UNKNOWN AND THE OUTCOME OF THE COUGH WAS NOT RECOVERED/NOT RESOLVED. THE REPORTER CONSIDERED THE CHOKE ON MEDICATION AND COUGH TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BREATHLESSNESS AND DEVICE USE IN UNAPPROVED INDICATION TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). THIS REPORT IS MADE BY HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE ADVERSE EVENT INFORMATION WAS RECEIVED FROM A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 10AUG2023. THE CONSUMER REPORTED THAT, "I AM A CONSUMER, I BOUGHT THE PRODUCT BIOTENE, I USE A C PACK. I GOT UP AND WOKE UP IN THE NIGHT WITH A VERY VERY DRY MOUTH. I GRAB THE BIOTENE DRY MOUTH AND SPRAYED IT IN MY MOUTH NOT THINKING I CHOKED REAL REAL BAD. I KEPT DRINKING WATER WATER I HAVE SPRAYED EVERYTHING IN MY MOUTH. COUGH SYRUP, COUGH DROPS, ITS EXCITED BUT I STILL HAVE A COUGH NOW FROM THE BIOTENE THAT CHOKED ME AND ITS STILL IN MY THROAT. I COULDN'T EVEN GOT MY BREATH, I CHOKED SO BAD. THAT DIDN'T HELP SO GOOD, I KEPT COUGHING AND COUGHING, I DRANK SOME MILK, I SPRAYED MY MOUTH WITH THAT THING WHEN YOU HAVE A SORE THROAT AND NOTHING HELPED ME. I JUST WANTED TO TOOK A CHANCE, MAYBE IN THE FUTURE YOU MIGHT HAVE SOMEONE THAT CAN ADVISE SOMETHING. I STILL HAVE A COUGH BUT NOT AS BAD. NO I DON'T WANT TO DO MEDICAL REPORT. I WILL CALL MY DOCTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121963 BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other