BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (ORIGINAL)

    MDR report key: 6948717 · Received October 13, 2017

    Report

    Report Number
    1718912-2017-00028
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 27, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K103745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT # 1718912-2017-00028 IS ASSOCIATED WITH (B)(4), BIOTENE MOUTH SPRAY (ORIGINAL).

    Description of Event or Problem · 1

    SHE SWALLOWED A LITTLE BIT AND STARTED CHOCKING [CHOKING]. SHE SWALLOWED A LITTLE BIT AND STARTED CHOCKING, GAGING, SHORTNESS OF BREATH [GAGGING]. SHE SWALLOWED A LITTLE BIT AND STARTED CHOCKING, GAGING, SHORTNESS OF BREATH [SHORTNESS OF BREATH]. BIOTENE DRY MOUTH MOISTURIZING SPRAY ON WEDNESDAY AS DIRECTED AND SHE SWALLOWED A LITTLE BIT [EXPOSURE VIA INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED LACTOPEROXIDASE, LYSOZYME (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER U6E281, EXPIRY DATE 30TH APRIL 2018) FOR DRY MOUTH. ON (B)(6) 2017, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON (B)(6) 2017, LESS THAN A DAY AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), GAGGING AND SHORTNESS OF BREATH. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXPOSURE VIA INGESTION. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, GAGGING, SHORTNESS OF BREATH AND EXPOSURE VIA INGESTION WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING, GAGGING AND SHORTNESS OF BREATH TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE EXPOSURE VIA INGESTION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER REPORTED SHE USED BIOTENE DRY MOUTH MOISTURIZING SPRAY ON WEDNESDAY AS DIRECTED AND SHE SWALLOWED A LITTLE BIT AND STARTED CHOCKING, GAGING, SHORTNESS OF BREATH. SHE WANTS AN INVESTIGATION. LOT CODE OF PRODUCT WAS U6E281 AND EXPIRY DATE WAS 30 APRIL 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727186 BIOTENE MOUTH SPRAY (ORIGINAL) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC U6E281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other