BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)

    MDR report key: 6129044 · Received November 28, 2016

    Report

    Report Number
    2011158-2016-00089
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 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 (ORIGINAL).

    Description of Event or Problem · 1

    ACCIDENTALLY INGESTED HALF OF A TABLESPOON OF THE BIOTENE ORIGINAL ORAL RINSE 128 OZ (ORIGINAL). 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, LACTOPEROXIDASE, LYSOZYME (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER (B)(4), EXPIRY DATE 30TH APRIL 2019) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), 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 (ORIGINAL). ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2016. THE CONSUMER REPORTED THEY ACCIDENTALLY INGESTED HALF OF A TABLESPOON OF THE BIOTENE ORIGINAL ORAL RINSE 128 OZ (ORIGINAL). THE CONSUMER DID NOT SPEAK TO A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779769 BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) ORAL RINSES LFD MARIETTA CORPORATION SE11N1

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other