BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)

    MDR report key: 6136102 · Received November 30, 2016

    Report

    Report Number
    2011158-2016-00093
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MARIETTA CORPORATION
    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 ORIGINAL ORAL RINSE.

    Description of Event or Problem · 1

    SHE ACCIDENTLY SWALLOWED SOME. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED GLUCOSE OXIDASE (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER (B)(4), EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (SAVANNAH), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF DRUG. BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND ACCIDENTAL INGESTION OF DRUG WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ADDITIONAL DETAILS, THE ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2016. CONSUMER REPORTED SHE ACCIDENTLY SWALLOWED SOME (ACCIDENTAL DEVICE INGESTION) (ACCIDENTAL INGESTION OF DRUG) AND SHE WANTED TO KNOW WHAT WAS GOING TO HAPPEN. CONSUMER STATED THAT SHE STARTED USE OF THE PRODUCT A WHILE AGO AND THAT SHE STARTED EXPERIENCING THE ADVERSE EVENT LAST NIGHT AROUND 2 OR 3 IN THE MORNING ((B)(6) 2016). SHE STATED THAT SHE STOPPED USE OF THE PRODUCT AS WELL AND DID NOT SPEAK WITH HER HEALTH CARE PROFESSIONAL. FOLLOW UP INFORMATION WAS RECEIVED ON 21 NOVEMBER 2016 VIA RETURNED CONSUMER AUTHORIZATION FORM. THE CONSUMER PROVIDE PERMISSION AND CONTACT DETAILS OF PHYSICIAN TO CONTACT FOR FURTHER FOLLOW UP.

    Description of Event or Problem · 1

    HE ACCIDENTLY SWALLOWED SOME. STOMATITIS. THRUSH. COUGH. SOME DISCOMFORT IN THE THROAT [PHARYNX DISCOMFORT]. HE FEELS THAT THIS BURNED HIS THROAT. SENSATION OF SOMETHING STUCK IN THE BACK OF THROAT [PHARYNGOLARYNX FOREIGN BODY FEELING]. HOARSENESS. PRESBYLARYNX. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED GLUCOSE OXIDASE (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER (B)(4), EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (SAVANNAH), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF DRUG. BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND ACCIDENTAL INGESTION OF DRUG WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ADDITIONAL DETAILS, THE ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2016. CONSUMER REPORTED SHE ACCIDENTLY SWALLOWED SOME (ACCIDENTAL DEVICE INGESTION) (ACCIDENTAL INGESTION OF DRUG) AND SHE WANTED TO KNOW WHAT WAS GOING TO HAPPEN. CONSUMER STATED THAT SHE STARTED USE OF THE PRODUCT A WHILE AGO AND THAT SHE STARTED EXPERIENCING THE ADVERSE EVENT LAST NIGHT AROUND 2 OR 3 IN THE MORNING ((B)(6) 2016). SHE STATED THAT SHE STOPPED USE OF THE PRODUCT AS WELL AND DID NOT SPEAK WITH HER HEALTH CARE PROFESSIONAL. FOLLOW UP INFORMATION WAS RECEIVED ON 21 NOVEMBER 2016 VIA RETURNED CONSUMER AUTHORIZATION FORM. THE CONSUMER PROVIDE PERMISSION AND CONTACT DETAILS OF PHYSICIAN TO CONTACT FOR FURTHER FOLLOW UP. FOLLOW UP INFORMATION WAS RECEIVED ON 30 JANUARY 2017 VIA ADVERSE EVENT REPORTING (AER) FORM BY PHYSICIAN. THE PHYSICIAN'S DETAILS WAS PROVIDED. CONSUMERS GENDER WAS UPDATED FROM FEMALE TO MALE. CONSUMER CONSULTED TO PHYSICIAN FOR THROAT ISSUE. THE CONSUMER STATED THAT HE HAD THRUSH. HE HAD SOME DISCOMFORT IN HIS THROAT AFTER USING BIOTENE MOUTH RINSE. HE FELT THAT THIS BURNED HIS THROAT. HE HAD A COUGH BECAUSE OF THIS. THE CONSUMER ALSO STATED AS SENSATION OF SOMETHING STUCK IN THE BACK OF THROAT. THE PHYSICIAN CONFIRMED THE DIAGNOSIS OF PRESBYLARYNX, DYSPHONIA AND STOMATITIS. PHYSICIAN ADVISED PATIENT TO TAKE CRIPP'S SOLUTION 4 TIMES DAILY FOR WEEK. DRINK MORE WATER AND AVOID THROAT CLEARING. STOMATITIS, THRUSH, COUGH, PHARYNX DISCOMFORT, THROAT BURNING SENSATION OF, PHARYNGOLARYNX FOREIGN BODY FEELING, HOARSENESS AND PRESBYLARYNX EVENTS WERE ADDED IN THIS CASE. ON AN UNKNOWN DATE, THE OUTCOME OF THE STOMATITIS, THRUSH, COUGH, PHARYNX DISCOMFORT, THROAT BURNING SENSATION OF, PHARYNGOLARYNX FOREIGN BODY FEELING, HOARSENESS AND PRESBYLARYNX WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE STOMATITIS, THRUSH, COUGH, PHARYNX DISCOMFORT, PHARYNGOLARYNX FOREIGN BODY FEELING, HOARSENESS AND PRESBYLARYNX TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). THE REPORTER CONSIDERED THE THROAT BURNING SENSATION OF TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786442 BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) ORAL RINSES LFD MARIETTA CORPORATION 6D06C3

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other