BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)

    MDR report key: 6011650 · Received October 7, 2016

    Report

    Report Number
    2011158-2016-00061
    Event Type
    Injury
    Date Received
    October 7, 2016
    Report Date
    August 15, 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 (SAVANNAH).

    Description of Event or Problem · 1

    SHE ACCIDENTALLY SWALLOWED THE PRODUCT/ SWALLOWED A SMALL AMOUNT OF BIOTENE. 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 30TH APRIL 2019) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AT AN UNKNOWN DOSE AND FREQUENCY. 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 ACCIDENTAL INGESTION OF DRUG. BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS CONTINUED WITH NO CHANGE. 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 RECEIVED ON 15 AUGUST 2016. THE CONSUMER REPORTED THAT SHE ACCIDENTALLY SWALLOWED THE PRODUCT (ACCIDENTAL DEVICE INGESTION/ ACCIDENTAL INGESTION OF DRUG). THE CONSUMER STATED THAT SHE HAD BEEN USING THE PRODUCT FOR 5 TO 6 YEARS AND WAS CURRENTLY STILL USING THE PRODUCT. THE CONSUMER STATED THAT SHE HAD NOT CONTACTED HER HEALTHCARE PROVIDER IN REGARDS TO HER CONCERNS. FOLLOW UP INFORMATION WAS RECEIVED ON 04 OCTOBER 2016 VIA RETURNED CONSUMER AUTHORIZATION FORM. THE CONSUMER REPORTED THAT, SHE ONLY SWALLOWED A SMALL AMOUNT OF BIOTENE SO SHE DID NOT SEEK MEDICAL TREATMENT. SHE WAS JUST FINE. THE CONSUMER STATED THAT, SHE MADE HER OWN DECISION. THE CONSUMER DID NOT PROVIDE THE PHYSICIAN DETAILS. HENCE, FURTHER FOLLOW WOULD NOT BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661483 BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) ORAL RINSES LFD MARIETTA CORPORATION 6E05C2A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other