BEUDAMED
    FDA Adverse Event Summary report: N

    BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION)

    MDR report key: 4478447 · Received February 2, 2015

    Report

    Report Number
    1718912-2015-00007
    Date Received
    February 2, 2015
    Date of Event
    December 24, 2014
    Report Date
    January 1, 2015
    Manufacturer
    ULTRADENT PRODUCTS, INC./ORATECH LLC
    Product Code
    NTO
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANAPHYLACTIC REACTION [ANAPHYLACTIC REACTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ANAPHYLACTIC REACTION IN A FEMALE PATIENT WHO RECEIVED ORAL MOISTURISERS (BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION)) MOUTH WASH (BATCH NUMBER 4F26C1, EXPIRY DATE UNKNOWN) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION). ON (B)(6) 2014, AN UNKNOWN TIME AFTER STARTING BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION), THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ANAPHYLACTIC REACTION WAS RECOVERED/RESOLVED. THE REPORTER CONSIDERED THE ANAPHYLACTIC REACTION TO BE RELATED TO BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION). ADDITIONAL DETAILS: CONSUMER REPORTED SHE HAD AN ANAPHYLACTIC REACTION ON (B)(6) 2014, AND BELIEVES IT WAS DUE TO THE BIOTENE MOUTH RINSE. IT WAS THE FIRST AND ONLY TIME SHE HAD EXPERIENCED AN ANAPHYLACTIC REACTION. AN AE REVISION WAS MADE ON (B)(6) 2015, AND THE REVISED INFORMATION IS INCLUDED IN THE ABOVE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75039 BIOTENE DRY MOUTH ORAL RINSE (2013 FORMULATION) ORAL RINSES NTO ULTRADENT PRODUCTS, INC./ORATECH LLC 4F26C1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other