BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)

    MDR report key: 6811572 · Received August 22, 2017

    Report

    Report Number
    9615332-2017-00088
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    August 18, 2017
    Manufacturer
    KIK CUSTOM PRODUCTS, REXDALE PLANT
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    9615332-2017-00088 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE ORIGINAL ORAL RINSE (SAVANNAH).

    Description of Event or Problem · 1

    MY HUSBAND SWALLOWS THIS WHEN HE USES IT/SWALLOWS ABOUT A MOUTHFUL [ACCIDENTAL DEVICE INGESTION], MY HUSBAND HAS DEMENTIA, AND HE IS IN THE PSYCH WARD OF THE HOSPITAL RIGHT NOW. [DEMENTIA]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER 6D26N1, EXPIRY DATE 31ST MARCH 2019) FOR DRY MOUTH. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER 7C071C, EXPIRY DATE 28TH FEBRUARY 2020) FOR DRY MOUTH. IN 2016, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), DEMENTIA (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT) AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS. BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS CONTINUED WITH NO CHANGE. BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) WAS CONTINUED WITH NO CHANGE. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, DEMENTIA AND WRONG TECHNIQUE IN DEVICE USAGE PROCESS WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND DEMENTIA TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) AND BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). ADDITIONAL DETAILS: THE CONSUMER'S WIFE REPORTED "MY HUSBAND HAS DEMENTIA, AND HE HAS BEEN USING THE BIOTENE ORIGINAL ORAL RINSE 16OZ (SAVANNAH) EVERY DAY. HE DRINKS IT FROM THE BOTTLE (WRONG TECHNIQUE IN DEVICE USAGE PROCESS), AND SWALLOWS ABOUT A MOUTHFUL (ACCIDENTAL DEVICE INGESTION). THE LOT NUMBER IS 6D26N1. I FILL THIS BOTTLE FROM THE BIOTENE ORIGINAL ORAL RINSE 33.8OZ (SAVANNAH) (WRONG TECHNIQUE IN DEVICE USAGE PROCESS). THE LOT NUMBER IS 7C071C. MY HUSBAND IS IN THE HOSPITAL RIGHT NOW. HE IS IN THE PSYCH WARD. I DON'T REMEMBER WHEN HE STARTED TO USE THESE BOTTLES, BUT HE HAS BEEN USING THE BIOTENE FOR ABOUT A YEAR. MY HUSBAND HAS DEMENTIA, AND HE IS IN THE PSYCH WARD OF THE HOSPITAL RIGHT NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590489 BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) ORAL RINSES LFD KIK CUSTOM PRODUCTS, REXDALE PLANT 6D26N1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O