BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)

    MDR report key: 6116968 · Received November 21, 2016

    Report

    Report Number
    2011158-2016-00087
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    November 17, 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

    REPORT # 2011158-2016-00087 IS ASSOCIATED WITH (B)(4), BIOTENE ORIGINAL ORAL RINSE.

    Description of Event or Problem · 1

    SWALLOWING SMALL AMOUNT OF BIOTENE ORAL RINSE 4 TIMES DAILY FOR 6 WEEKS AT LEAST [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED GLUCOSE OXIDASE (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. IN (B)(6) 2016, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AT AN UNKNOWN DOSE 4 TIMES DAILY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (SAVANNAH), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL INGESTION OF DRUG. 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, ADVERSE EVENT INFORMATION WAS REPORTED ON 17 NOVEMBER 2016. THE CONSUMER REPORTED SWALLOWING SMALL AMOUNT OF BIOTENE ORAL RINSE 4 TIMES DAILY FOR 6 WEEKS AT LEAST, SHE STATED. CONSUMER REPORTED INDICATED USE OF DRY MOUTH. PROVIDED CONSUMER WITH POISON CONTROL NUMBER, SHE STATED SHE DID NOT FEEL THE NEED TO CONTACT HER HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769510 BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) ORAL RINSES LFD MARIETTA CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other