BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL BALANCE GEL (AROMA)

    MDR report key: 5541029 · Received April 1, 2016

    Report

    Report Number
    1718912-2016-00013
    Event Type
    Injury
    Date Received
    April 1, 2016
    Report Date
    March 23, 2016
    Manufacturer
    ULTRADENT PRODUCTS INC./ ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT 1718912-2016-00013 IS ASSOCIATED WITH ARGUS CASE (B)(4) BIOTENE ORAL BALANCE GEL (AROMA).

    Description of Event or Problem · 1

    ASPIRATED SOME BIOTENE GEL [MEDICATION ASPIRATION], RESPIRATORY COMPLICATION ASSOCIATED WITH DEVICE [RESPIRATORY COMPLICATION ASSOCIATE WITH DEVICE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF MEDICATION ASPIRATION IN A (B)(6) MALE PATIENT WHO RECEIVED GLUCOSE OXIDASE (BIOTENE ORAL BALANCE GEL (AROMA)) GEL (BATCH NUMBER W4N081, EXPIRY DATE 30TH NOVEMBER 2017) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL (AROMA) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL (AROMA), THE PATIENT EXPERIENCED MEDICATION ASPIRATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND RESPIRATORY COMPLICATION ASSOCIATED WITH DEVICE. BIOTENE ORAL BALANCE GEL (AROMA) WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE MEDICATION ASPIRATION WAS RECOVERED/RESOLVED AND THE OUTCOME OF THE RESPIRATORY COMPLICATION ASSOCIATED WITH DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE MEDICATION ASPIRATION AND RESPIRATORY COMPLICATION ASSOCIATED WITH DEVICE TO BE RELATED TO BIOTENE ORAL BALANCE GEL (AROMA). ADDITIONAL DETAILS, THE CONSUMER STATED THAT HE ASPIRATED SOME BIOTENE GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196424 BIOTENE ORAL BALANCE GEL (AROMA) ORAL GEL LFD ULTRADENT PRODUCTS INC./ ORATECH LLC W4N081

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other