BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (SAVANNAH)

    MDR report key: 6681527 · Received June 30, 2017

    Report

    Report Number
    1718912-2017-00019
    Event Type
    Injury
    Date Received
    June 30, 2017
    Report Date
    June 23, 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

    1718912-2017-00019 IS ASSOCIATED WITH ARGUS CASE (B)(4) BIOTENE MOUTH SPRAY.

    Additional Manufacturer Narrative · 1

    MFR 1718912-2017-00019 IS ASSOCIATED WITH ARGUS CASE (B)(4) BIOTENE MOUTH SPRAY.

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF PARALYSIS IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. IN (B)(6) 2017, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), THE PATIENT EXPERIENCED PARALYSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SEIZURE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (SAVANNAH) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE PARALYSIS AND SEIZURE WERE UNKNOWN. THE REPORTER CONSIDERED THE PARALYSIS AND SEIZURE TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL FROM POWERREVIEWS ON 23 JUNE 2017. CONSUMER REPORTED ADVERSE EVENT WHILE USING BIOTENE MOUTH SPRAY (SAVANNAH). THE CONSUMER STATED, "I WOULD NOT RECOMMEND BIOTENE, AFTER TAKING THIS PRODUCT FOR 2 MONTHS ((B)(6)) 2017) LIKE IT SAID, I BELIEVE THIS GAVE ME MY FIRST SEIZURE WITH PARALYSIS FOR 10 MINUTES FOLLOWING THE SEIZURE. I AM NOW ON MY WAY THIS MORNING TO SEE A NEUROLOGIST TO LET THEM KNOW THAT I BELIEVE IT IS THIS PRODUCT. IF YOU READ THE SIDE AFFECTS IT STATES IT RIGHT ON THERE THAT THIS COULD HAPPEN." FOLLOW-UP INFORMATION WAS RECEIVED ON 12 JULY 2017. THE CONSUMER PROVIDED THE LOT NUMBER AS U7B031, EXPIRATION DATE AS 31 DECEMBER 2018 FOR BIOTENE MOUTH SPRAY (SAVANNAH) AND HER AGE AS 52 YEARS OLD. ALSO STATED SHE FOLLOWED UP WITH A HCP (HEALTHCARE PROVIDER) AND REQUESTED THE HCP (HEALTHCARE PROVIDER) FORM.

    Description of Event or Problem · 1

    I BELIEVE THIS GAVE ME MY FIRST SEIZURE WITH PARALYSIS FOR 10 MINUTES FOLLOWING THE SEIZURE [PARALYSIS], I BELIEVE THIS GAVE ME MY FIRST SEIZURE WITH PARALYSIS FOR 10 MINUTES FOLLOWING THE SEIZURE [SEIZURE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF PARALYSIS IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (SAVANNAH)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE FOR UNKNOWN INDICATION. IN (B)(6) 2017, THE PATIENT STARTED BIOTENE MOUTH SPRAY (SAVANNAH). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (SAVANNAH), THE PATIENT EXPERIENCED PARALYSIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SEIZURE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (SAVANNAH) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE PARALYSIS AND SEIZURE WERE UNKNOWN. THE REPORTER CONSIDERED THE PARALYSIS AND SEIZURE TO BE RELATED TO BIOTENE MOUTH SPRAY (SAVANNAH). ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL FROM POWER REVIEWS ON 23 JUNE 2017. CONSUMER REPORTED ADVERSE EVENT WHILE USING BIOTENE MOUTH SPRAY (SAVANNAH). THE CONSUMER STATED, "I WOULD NOT RECOMMEND BIOTENE, AFTER TAKING THIS PRODUCT FOR 2 MONTHS ((B)(6) 2017) LIKE IT SAID, I BELIEVE THIS GAVE ME MY FIRST SEIZURE WITH PARALYSIS FOR 10 MINUTES FOLLOWING THE SEIZURE. I AM NOW ON MY WAY THIS MORNING TO SEE A NEUROLOGIST TO LET THEM KNOW THAT I BELIEVE IT IS THIS PRODUCT. IF YOU READ THE SIDE AFFECTS IT STATES IT RIGHT ON THERE THAT THIS COULD HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463621 BIOTENE MOUTH SPRAY (SAVANNAH) ORAL SPRAY LFD ULTRADENT PRODUCTS INC./ ORATECH LLC U7B031

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other