BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 6136080 · Received November 30, 2016

    Report

    Report Number
    1718912-2016-00035
    Event Type
    Injury
    Date Received
    November 30, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE MOUTH SPRAY.

    Description of Event or Problem · 1

    CHOKING.] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT, LIFE THREATENING AND OTHER: GSK MEDICALLY SIGNIFICANT ). THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (SAVANNAH) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION RECEIVED ON 28 NOVEMBER 2016. THE REPORTER CALLED IN TO INQUIRE WHAT SHOULD BE DONE IF THE CONSUMER WAS CHOKING ON BIOTENE MOUTH SPRAY 1.5OZ (SAVANNAH). WHAT DO WE DO IF SOMEONE WAS CHOKING ON THE "BI". THEY SPRAYED IT ON THEIR TONGUE AND THEY WERE FINE AND THEN THEY SPRAYED IT ON THEIR MOUTH AND NOW THEY WERE CHOKING AS IF IT WENT DOWN THE WRONG PIPE. ASKED WHAT COULD BE IN THE PRODUCT TO CAUSE CHOKING. THE REPORTER WAS ADVISED TO IMMEDIATELY CONTACT EMERGENCY SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786654 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O