BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 6271314 · Received January 23, 2017

    Report

    Report Number
    1718912-2017-00004
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    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 MOUTH SPRAY (SAVANNAH).

    Description of Event or Problem · 1

    CHOKING. THROAT REDNESS. UNCONTROLLABLE COUGH. SORE THROAT. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER (B)(4), EXPIRY DATE 28TH FEBRUARY 2018) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH). ON (B)(6) 2017, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), RED THROAT, COUGH AND SORE THROAT. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (SAVANNAH) WAS UNKNOWN. ON (B)(6) 2017, THE OUTCOME OF THE CHOKING, COUGH AND SORE THROAT WERE RECOVERED/RESOLVED. ON AN UNKNOWN DATE, THE OUTCOME OF THE RED THROAT WAS RECOVERING/RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, RED THROAT, COUGH AND SORE THROAT TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS REPORTED BY CONSUMER ON (B)(6) 2017. CONSUMER REPORTED THAT SHE USED PRODUCT THIS MORNING AND SHE STARTED CHOKING, COUGHING UNCONTROLLABLY AND TURNED HER THROAT RED. SHE STATED HER THROAT REDNESS WAS STILL LINGERING. SHE STATED SHE DRANK MILK TO HELP WITH HER CONDITIONS, WHICH SLIGHTLY IMPROVED THEM, BUT NOT COMPLETELY. CONSUMER HAD NOT CONSULTED AN HEALTHCARE PROFESSIONAL BUT STATED SHE MIGHT GO TO THE EMERGENCY ROOM IF HER CONDITION DID NOT IMPROVE. THE CONSUMER PROVIDED THE EXPIRY DATE OF 28 FEBRUARY 2018. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER REPORTED HER THROAT WAS ALSO SORE AFTER USING OUR PRODUCT. SHE STATED SHE DID NOT GO TO HER EYE DOCTOR APPOINTMENT, LIKE SHE INITIALLY PLANNED TO, BUT SHE STATED THAT HER CHOKING, COUGHING AND THROAT SORENESS HAD ALL BUT COMPLETELY SUBSIDED WITH SOME SLIGHT REDNESS STILL REMAINING IN HER THROAT. SHE STATED SHE WAS USING THE PRODUCT FOR MONTHS, BUT COULD NOT SPECIFY EXACTLY WHEN SHE STARTED USING THE PRODUCT, STATING SHE WOULD ONLY USE THE PRODUCT WHEN NECESSARY. ADVERSE EVENT START DATE WAS (B)(6) 2017 AND END ON (B)(6) 2017. CONSUMER STATED HER THROAT REDNESS WAS SUBSIDING BUT STILL PRESENT. THE CONSUMER PROVIDE THE LOT CODE OF U6C071. INITIAL AND FOLLOW UP INFORMATION WAS INCLUDED IN ABOVE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52451 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC U6C071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other