BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (ORIGINAL)

    MDR report key: 8103192 · Received November 26, 2018

    Report

    Report Number
    3012293198-2018-00014
    Event Type
    Injury
    Date Received
    November 26, 2018
    Report Date
    November 20, 2018
    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 · 1

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

    Description of Event or Problem · 1

    WENT DIRECTLY ON HIS THROAT AND ITS CHOKING HIM [CHOKING], I AM CALLING TO REPORT THAT MY HUSBAND ACCIDENTALLY SWALLOWED THE BIOTENE SPRAY LIQUID [ACCIDENTAL DEVICE INGESTION], EXPIRATION DATE IS 31 "JULLY" 2018 [EXPIRED DEVICE USED]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER U6J221, EXPIRY DATE 31ST JULY 2018) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND EXPIRED DEVICE USED. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL DEVICE INGESTION AND EXPIRED DEVICE USED WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING AND ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE EXPIRED DEVICE USED TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 20 NOVEMBER 2018. CONSUMER STATED, "I AM CALLING TO REPORT THAT MY HUSBAND ACCIDENTALLY SWALLOWED THE BIOTENE SPRAY, WHEN HE SPRAYED IT, IT WENT DIRECTLY ON HIS THROAT AND 'ITS' CHOKING HIM REALLY BAD. I WANT TO KNOW WHAT IN THE PRODUCT "THAT" MIGHT BE BAD FOR HIM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940608 BIOTENE MOUTH SPRAY (ORIGINAL) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC U6J221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other