BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)

    MDR report key: 6082562 · Received November 7, 2016

    Report

    Report Number
    1718912-2016-00033
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1718912-2016-00033 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE MOISTURIZING MOUTH SPRAY.

    Description of Event or Problem · 1

    CHOKING [CHOKING]. COUGH [COUGH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A NON-HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR UNKNOWN INDICATION. 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 CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND COUGH. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND COUGH WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING AND COUGH TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: IT WAS REPORTED THAT THE PRODUCT "SHOOTS OUT LIKE A JET" AND THIS CAUSED THE PATIENT TO CHOKE IT IN, AND IT MADE HER COUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732810 BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other