BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOTENE MOISTURIZING MOUTH SPRAY

    MDR report key: 5017548 · Received August 18, 2015

    Report

    Report Number
    1718912-2015-00017
    Event Type
    Other
    Date Received
    August 18, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 7, 2015
    Manufacturer
    ULTRADENT PRODUCTS, INC./ORATECH LLC
    Product Code
    LFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SOME CHOKING, SWOLLEN TONGUE, DIFFICULTY BREATHING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A PHARMACIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) YEAR OLD MALE PATIENT WHO RECEIVED LACTOPEROXIDASE, LYSOZYME (BIOTENSE MOISTURIZING MOUTH SPRAY) UNKNOWN (BATCH NUMBER (B)(4), EXPIRY DATE OCTOBER 2016) FOR DRY MOUTH. IN (B)(6) 2015, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY AT AN UNKNOWN DOSE AND FREQUENCY. ON (B)(6) 2015, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SWOLLEN TONGUE AND DIFFICULTY BREATHING. BIOTENE MOISTURIZING MOUTH SPRAY WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, SWOLLEN TONGUE AND DIFFICULTY BREATHING WERE RECOVERED/RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, SWOLLEN TONGUE AND DIFFICULTY BREATHING TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY. ADDITIONAL INFORMATION, THE CASE WAS REPORTED BY A PHARMACIST VIA GENPACT HUB. THE PATIENT BOUGHT THE PRODUCT IN EARLY (B)(6) AND USED IT A WEEK AGO. HE FELT THE SYMPTOMS START ON (B)(6) 2015 IMMEDIATELY AFTER USING IT. THE SWOLLEN TONGUE WAS DESCRIBED AS "SEVERE". HE USED COLD WATER TO RELIEVE THE SYMPTOMS. HE IS NO LONGER EXPERIENCING THE SYMPTOMS. THE CONSUMER ALSO COMPLAINED ABOUT THE PRODUCT COMING OUT AS A SOLID STREAM AND NOT AS A SPRAY. HE DID NOT CONSULT HIS HCP ABOUT THE SYMPTOMS. NO FOLLOW-UP WILL BE CONDUCTED AS THE EVENTS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544436 BIOTENE MOISTURIZING MOUTH SPRAY ORAL SPRAY LFD ULTRADENT PRODUCTS, INC./ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other