BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 6756893 · Received August 1, 2017

    Report

    Report Number
    1718912-2017-00023
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 27, 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 (B)(4), BIOTENE MOUTH SPRAY.

    Description of Event or Problem · 1

    I ALMOST CHOKED ON IT, THROAT AND STARTS BURNING. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON (B)(6) 2017, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH). ON (B)(6) 2017, LESS THAN A DAY AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND BURNING IN THROAT. BIOTENE MOUTH SPRAY (SAVANNAH) WAS DISCONTINUED ON (B)(6) 2017 (DECHALLENGE WAS POSITIVE). ON (B)(6) 2017, THE OUTCOME OF THE CHOKING WAS RECOVERED/RESOLVED. ON AN UNKNOWN DATE, THE OUTCOME OF THE BURNING IN THROAT WAS NOT RECOVERED/NOT RESOLVED. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BURNING IN THROAT TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). ADDITIONAL DETAILS, THIS ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER USED BIOTENE SPRAY 1.5 OZ. HE HAD BEEN USING THESE PRODUCTS FOR MANY YEARS PRIMARILY THE GEL AND RINSE. LAST WEEK HE TRIED THE SPRAY AND IT DID NOT SPRAY. IT CAME OUT AS A STREAM AND WENT TO THE BACK OF HIS THROAT AND STARTED BURNING. IT DID NOT COME OUT AS A SPRAY, IT CAME OUT AS A SOLID STREAM AND IT STARTED TO BURN A LITTLE BIT. THERE WAS NO WAY TO PUT THIS ON YOUR TONGUE, IT WENT TO THE BACK OF HER THROAT AND IT BURNED A LITTLE BIT. HE HAD BEEN USING BIOTENE FOR YEARS, THE RINSE AND THE GEL BUT THE SPRAY WAS AN ABSOLUTE FRAUD AND IT WAS VERY EXPENSIVE. HE STARTED USING THE SPRAY 2 DAYS AGO ON (B)(6) 2017, HE HAD TO STOP. HE STOPPED THIS MORNING ON (B)(6) 2017. HE WOULD GO BACK TO USING OTHER BIOTENE PRODUCTS, NOT THIS PRODUCT. HE DID NOT THINK YOU SHOULD BE PROMOTING IT AS A SPRAY. IT CAME OUT AS A STREAM, NOT A SPRAY LIKE ON THE PACKAGING. HE HAD THE BURNING ON (B)(6) 2017. HE ALMOST CHOKED ON IT, IT WENT ALL THE WAY TO THE BACK OF HIS THROAT. THE BURNING IT NOT GONE. HE WAS NOT GOING TO USE THIS ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538606 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other