BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTENE PBF ORAL RINSE (ORIGINAL)

    MDR report key: 6537290 · Received May 2, 2017

    Report

    Report Number
    9615332-2017-00029
    Event Type
    Death
    Date Received
    May 2, 2017
    Report Date
    April 20, 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 PBF ORAL RINSE (ORIGINAL).

    Description of Event or Problem · 1

    PASSED AWAY [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A MALE PATIENT WHO RECEIVED DEXTRANASE, GLUCOSE OXIDASE, LACTOPEROXIDASE, LYSOZYME, MUTANASE (BIOTENE PBF ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 3D10C1, EXPIRY DATE 31ST MARCH 2016) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE PBF ORAL RINSE (ORIGINAL). IN 2016, AN UNKNOWN TIME AFTER STARTING BIOTENE PBF ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). IN 2016, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL. THE PATIENT DIED IN 2016. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE RELATED TO BIOTENE PBF ORAL RINSE (ORIGINAL). ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 20 APRIL 2017. THE CONSUMER REPORTED THAT THEY HAD ORIGINALLY PURCHASED THIS BIOTENE PBF ORAL RINSE 16 FL OZ. FOR HUSBAND, BUT HE PASSED AWAY SOMETIME LAST YEAR. HE DID USE IT BEFORE HE DIED. SHE PURCHASED IT THE YEAR BEFORE. HE WAS IN A FACILITY AND SHE NOTICED THE BOTTLE WAS HERE. HE WAS USING IT FOR DRY MOUTH. HE WAS IN HIS LATE 80S. THIS CASE WAS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317586 BIOTENE PBF ORAL RINSE (ORIGINAL) ORAL RINSES LFD KIK CUSTOM PRODUCTS, REXDALE PLANT 3D10C1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O