BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE PBF ORAL RINSE (ORIGINAL)

    MDR report key: 6016679 · Received October 11, 2016

    Report

    Report Number
    2011158-2016-00059
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    September 27, 2016
    Manufacturer
    MARIETTA CORPORATION
    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 PBF ORAL RINSE (ORIGINAL).

    Description of Event or Problem · 1

    BEGAN TO SPIT UP BLACK TAR [DARK COLOR VOMITING]. EXPERIENCED A IRRITATED THROAT [THROAT IRRITATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DARK COLOR VOMITING IN A (B)(6) MALE PATIENT WHO RECEIVED DEXTRANASE, GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME, MUTANASE (BIOTENE PBF ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 6D25C2, EXPIRY DATE 30TH APRIL 2016) FOR DRY MOUTH. CONCOMITANT PRODUCTS INCLUDED HYDROCHLOROTHIAZIDE AND HYDROCODONE BITARTRATE + PARACETAMOL (NORCO). ON (B)(6) 2016, THE PATIENT STARTED BIOTENE PBF ORAL RINSE (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE PBF ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED DARK COLOR VOMITING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), THROAT IRRITATION AND EXPIRED DRUG USED. BIOTENE PBF ORAL RINSE (ORIGINAL) WAS DISCONTINUED ON (B)(6) 2016 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE DARK COLOR VOMITING AND THROAT IRRITATION WERE RECOVERED/RESOLVED AND THE OUTCOME OF THE EXPIRED DRUG USED WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DARK COLOR VOMITING AND THROAT IRRITATION TO BE RELATED TO BIOTENE PBF ORAL RINSE (ORIGINAL). ADDITIONAL DETAILS: THE ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2016. THE CONSUMER REPORTED THAT WHILE USING THE PRODUCT, TWO OR THREE DAYS AFTER THE START DATE HE EXPERIENCED A IRRITATED THROAT. THE CONSUMER THEN REPORTED THAT WELL INTO THE USE OF THE PRODUCT THE CONSUMER BEGAN TO SPIT UP BLACK TAR. THE CONSUMER HAD MEDICAL HISTORY THAT RESULTS IN HIM TAKING BIOTENE TO HELP WITH HIS DRY MOUTH. THE CONSUMER WAS USING SIX CONCOMITANT PRODUCTS. UPON WITHDRAWING FROM THE PRODUCT THE CONSUMER NO LONGER EXPERIENCED THE IRRITATED THROAT NOR THE VOMIT. THE CONSUMER WOULD BE MEETING WITH HIS HEALTH CARE PROFESSIONALS. THE CONCOMITANT MEDICATIONS INCLUDED BEYER ASPIRIN, CARBEBILOL, COREUG AND VIALUM .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667761 BIOTENE PBF ORAL RINSE (ORIGINAL) ORAL RINSES LFD MARIETTA CORPORATION 6D25C2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other