BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (UNKNOWN)

    MDR report key: 16252553 · Received January 27, 2023

    Report

    Report Number
    3012293198-2023-00002
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 3, 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

    IT GOT INTO MY AIRWAY [ACCIDENTAL DEVICE INGESTION]. MY THROAT GOT CONSTRICTED [THROAT CONSTRICTION]. I COULDN´T BREATHE [DIFFICULTY BREATHING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A 68-YEAR-OLD FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (UNKNOWN)) OROMUCOSAL SPRAY (BATCH NUMBER BPB9N, EXPIRY DATE 28TH AUGUST 2025) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (UNKNOWN). ON (B)(6) 2023, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (UNKNOWN), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), THROAT CONSTRICTION AND DIFFICULTY BREATHING. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (UNKNOWN) WAS UNKNOWN. ON (B)(6) 2023, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, THROAT CONSTRICTION AND DIFFICULTY BREATHING WERE RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, THROAT CONSTRICTION AND DIFFICULTY BREATHING TO BE RELATED TO BIOTENE MOUTH SPRAY (UNKNOWN). THIS REPORT IS MADE BY GSK/HALEON WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED BY CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 03JAN2023. CONSUMER REPORTED THAT "LAST NIGHT I SPRAYED THE BIOTENE IN MY MOUTH AND IT GOT INTO MY AIRWAY AND MY THROAT GOT CONSTRICTED AND I COULDN'T BREATHE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408083 BIOTENE MOUTH SPRAY (UNKNOWN) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC BPB9N

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other