BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)

    MDR report key: 6401232 · Received March 13, 2017

    Report

    Report Number
    9615332-2017-00008
    Event Type
    Death
    Date Received
    March 13, 2017
    Report Date
    February 1, 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

    THIS REPORT IS ASSOCIATED WITH ARGUS (B)(4), BIOTENE ORIGINAL ORAL RINSE (SAVANNAH).

    Description of Event or Problem · 1

    HER HUSBAND DIED ON (B)(6) 2017 [UNKNOWN CAUSE OF DEATH]. SWALLOWED SOME OF THE PRODUCT TODAY (B)(6) 2017/ ACCIDENTLY SWALLOWED LESS THAN A TABLE SPOON OF BIOTENE ORIGINAL ORAL RINSE 2OZ (SAVANNAH) [ACCIDENTAL DEVICE INGESTION]. SWALLOWED SOME OF THE PRODUCT TODAY (B)(6) 2017/ ACCIDENTLY SWALLOWED LESS THAN A TABLE SPOON OF BIOTENE ORIGINAL ORAL RINSE 2OZ (SAVANNAH) [ACCIDENTAL INGESTION OF PRODUCT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)) MOUTH WASH (BATCH NUMBER 6F24N1, EXPIRY DATE 31ST MAY 2019) FOR DRY MOUTH AND CANCER. ON (B)(6) 2017, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). 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), ACCIDENTAL INGESTION OF PRODUCT, DRUG USE FOR UNAPPROVED INDICATION AND DEVICE USE IN UNAPPROVED INDICATION. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, ACCIDENTAL INGESTION OF PRODUCT, DRUG USE FOR UNAPPROVED INDICATION AND DEVICE USE IN UNAPPROVED INDICATION 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 (B)(6) 2017. CONSUMER REPORTED THAT HER HUSBAND ACCIDENTLY SWALLOWED LESS THAN A TABLE SPOON OF BIOTENE ORIGINAL ORAL RINSE 2OZ (SAVANNAH). CONSUMER ACCIDENTLY SWALLOWED SOME OF THE PRODUCT TODAY ON (B)(6) 2017. CONSUMER WAS GIVEN THIS PRODUCT BY A FRIEND WHO HAD DRY MOUTH AS WELL. CONSUMER HAD CANCER AND THAT WAS WHY CONSUMER WAS USING THE BIOTENE AS WELL. CONSUMER WAS GOING TO CALL POISON CONTROL. REVISION OF INFORMATION RECEIVED IN INITIAL REPORT RECEIVED ON (B)(6) 2017. DRUG USE FOR UNAPPROVED INDICATION AND DEVICE USE IN APPROVED INDICATION REMOVED AS ADVERSE EVENTS. CANCER REMOVED AS AN INDICATION FOR BIOTENE ORIGINAL ORAL RINSE (SAVANNAH). THE CONSUMER HAD A MEDICAL HISTORY OF CANCER. FOLLOW UP INFORMATION WAS RECEIVED VIA PHONE ON 07 MARCH 2017. CONSUMER REPORTED NEW ADVERSE EVENT OF DEATH NOS OF HER HUSBAND. CONSUMER CALLED WITH THE COMPLAINT OF RECEIVING THE DOCTOR CONSENT LETTER TWICE AFTER HAVING REPORTED THE PREVIOUS EVENT OF ACCIDENTAL INGESTION OF BIOTENE BY HER HUSBAND. CONSUMER REPORTED DURING THE CALL HER HUSBAND DIED RECENTLY ON (B)(6) 2017. CONSUMER DECLINED FURTHER CONTACT. THE EVENT OF DEATH WAS ADDED TO THE CASE. THE OUTCOME OF DEATH WAS FATAL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (SAVANNAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183826 BIOTENE ORIGINAL ORAL RINSE (SAVANNAH) ORAL RINSES LFD KIK CUSTOM PRODUCTS, REXDALE PLANT 6F24N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death