BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTENE UNKNOWN

    MDR report key: 6213789 · Received December 29, 2016

    Report

    Report Number
    1718912-2016-00039
    Event Type
    Death
    Date Received
    December 29, 2016
    Report Date
    December 23, 2016
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1718912-2016-00039 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE UNKNOWN.

    Description of Event or Problem · 1

    DEATH [DEATH]; BAD REACTION [ADVERSE DRUG REACTION]; UNABLE TO SWALLOW FOOD [SWALLOWING DIFFICULT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF DEATH IN A MALE PATIENT WHO RECEIVED GLUCOSE OXIDASE (BIOTENE UNKNOWN) UNKNOWN FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE UNKNOWN AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE UNKNOWN, THE PATIENT EXPERIENCED DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT), ADVERSE DRUG REACTION (SERIOUS CRITERIA HOSPITALIZATION) AND SWALLOWING DIFFICULT. THE ACTION TAKEN WITH BIOTENE UNKNOWN WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE DEATH WAS FATAL AND THE OUTCOME OF THE ADVERSE DRUG REACTION AND SWALLOWING DIFFICULT WERE NOT REPORTED. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH AND SWALLOWING DIFFICULT TO BE RELATED TO BIOTENE UNKNOWN. THE REPORTER CONSIDERED THE ADVERSE DRUG REACTION TO BE RELATED TO BIOTENE UNKNOWN. ADDITIONAL DETAILS, THE CONSUMER'S WIFE REPORTED VIA (B)(6) THAT BIOTENE PUT HER LATE HUSBAND IN HOSPITAL FOR FIVE DAYS BECAUSE HE HAD A BAD REACTION TO IT. THE CONSUMER'S WIFE INDICATED THAT RIGHT AFTER TAKING THE PRODUCT HE WAS UNABLE TO SWALLOW ANY FOOD AND HE WENT IMMEDIATELY TO EMERGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864587 BIOTENE UNKNOWN UNKNOWN LFD ULTRADENT PRODUCTS INC./ ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O