BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (UNKNOWN)

    MDR report key: 10362162 · Received August 4, 2020

    Report

    Report Number
    3012293198-2020-00056
    Event Type
    Injury
    Date Received
    August 4, 2020
    Report Date
    July 9, 2020
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    ALL OTHER PRODUCTS SO NOT CONTAIN SODIUM SACCHARIN (SWEET AND LOW KIND OF ARTIFICIAL SWEETENER THAT CAUSE ANAPHYLAXIS TO ME [ANAPHYLAXIS]. IT ALMOST KILLED ME BY ALLERGIC REACTION TO SACCHARIN [IMPENDING DOOM]. IT ALMOST KILLED ME BY ALLERGIC REACTION / THE SPRAY CAN KILL ME [ALLERGIC REACTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ANAPHYLAXIS IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (UNKNOWN)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. CONCURRENT MEDICAL CONDITIONS INCLUDED DRUG ALLERGY. CONCOMITANT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORAL BALANCE GEL). ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (UNKNOWN). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (UNKNOWN) AND BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED ANAPHYLAXIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT), IMPENDING DOOM AND ALLERGIC REACTION. THE PATIENT WAS TREATED WITH AMBIGUOUS MEDICATION NOS (EPIPEN (NOS)). THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (UNKNOWN) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ANAPHYLAXIS, IMPENDING DOOM AND ALLERGIC REACTION WERE UNKNOWN. THE REPORTER CONSIDERED THE ANAPHYLAXIS, IMPENDING DOOM AND ALLERGIC REACTION TO BE RELATED TO BIOTENE MOUTH SPRAY (UNKNOWN). ADDITIONAL INFORMATION. ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL CENTER REPRESENTATIVE (EMAIL) ON 09 JULY 2020. CONSUMER REPORTED THAT, "GOOD EVENING, I JUST WANTED TO GIVE YOU SOME FEEDBACK. I RECENTLY PURCHASED THE DRY MOUTH SPRAY. I LOVE THE DRY MOUTH GEL BUT ONE POPPED OPEN AND SMEARED THE ENTIRE CONTENTS OVER EVERYTHING IN MY PURSE (IT WAS MESSY, IT WAS EXPENSIVE. MAYBE A TIGHTER CLOSING CAP?) SO I PURCHASE THE SPRAY. ALL OTHER PRODUCTS SO NOT CONTAIN SODIUM SACCHARIN (SWEET AND LOW KIND OF ARTIFICIAL SWEETENER THAT CAUSE ANAPHYLAXIS TO ME). I SHOULD HAVE CHECKED, IT IS MY FAULT, BUT TO MY KNOWLEDGE THIS IS THE FIRST BIOTENE PRODUCT WITH SACCHARIN IN IT. LONG STORY SHORT, I AM OUT QUITE A BIT OF, I'M DOWN ONE EPIPEN, THREW AWAY A PURSE AND KEEP FINDING GOOPY STUFF TO THIS DAY. SO NOT A FAN OF THE SPRAY. TLDR IT ALMOST KILLED ME BY ALLERGIC REACTION TO SACCHARIN BECAUSE THEY DO NOT USE IT IN OTHER PRODUCTS AND THE GEL ROCKS BUT DOES OPEN AND SPREADS GOOP EVERYWHERE, FOR YEARS. LOVE THE MOUTHWASH AND THE GEL, BUT CANNOT USE THE GEL WITHOUT THE MESS AND THE SPRAY CAN KILL ME. HAVE A GREAT DAY, PLEASE CONSIDER A NEW CAP FOR THE GEL OR INDIVIDUAL PACKAGE ARE GREAT, ALSO, PLEASE GET RID OF SACCHARIN SINCE IT IS CANCER CAUSING AND MY DAD RECENTLY PASSED AWAY FROM CANCER. SO PLEASE, USE SPLENDA. USE STEVIA. ANYTHING BUT CANCEROUS CHEMICALS. PLEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825424 BIOTENE MOUTH SPRAY (UNKNOWN) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other