BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL BALANCE GEL

    MDR report key: 7385345 · Received March 30, 2018

    Report

    Report Number
    1718912-2018-00005
    Event Type
    Injury
    Date Received
    March 30, 2018
    Date of Event
    February 10, 2018
    Report Date
    March 27, 2018
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SUFFOCATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN RESPIRATORY TRACT. BIOTENE ORAL BALANCE GEL WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE SUFFOCATION WAS NOT REPORTED AND THE OUTCOME OF THE FOREIGN BODY IN RESPIRATORY TRACT WAS UNKNOWN. THE REPORTER CONSIDERED THE SUFFOCATION TO BE PROBABLY RELATED TO BIOTENE ORAL BALANCE GEL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN RESPIRATORY TRACT TO BE RELATED TO BIOTENE ORAL BALANCE GEL. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A WHOLESALER EMPLOYEE, WHO RECEIVED THIS CASE FROM A HOSPITAL. (B)(6) 2018 THE PATIENT NEARLY SUFFOCATED DUE TO BIOTENE ORAL BALANCE GEL, THE GEL ENTERED THE LUNGS OF THE PATIENT. THE FOLLOWING BATCH NUMBERS WERE RETURNED TO THE WHOLESALER BY THE HOSPITAL: 101199, 5144526 (EXPIRY DATE: APR-2020), 5144966 (EXPIRY DATE: AUG-2020). FOLLOW UP WAS RECEIVED ON (B)(6) 2018: THIS CASE WAS REGARDING BATCH NUMBER 5144526, EXPIRY DATE APRIL 2020. THE REPORTER CONSIDERED THE SUFFOCATION TO BE RELATED TO BIOTENE ORAL BALANCE GEL.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH (B)(4), BIOTENE ORAL BALANCE GEL.

    Description of Event or Problem · 1

    NEAR SUFFOCATION [SUFFOCATION]. GEL ENTERED THE LUNGS [FOREIGN BODY IN RESPIRATORY TRACT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SUFFOCATION IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL) GEL FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL. ON (B)(6) 2018, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL, THE PATIENT EXPERIENCED SUFFOCATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND LIFE THREATENING). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FOREIGN BODY IN RESPIRATORY TRACT. BIOTENE ORAL BALANCE GEL WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE SUFFOCATION WAS NOT REPORTED AND THE OUTCOME OF THE FOREIGN BODY IN RESPIRATORY TRACT WAS UNKNOWN. THE REPORTER CONSIDERED THE SUFFOCATION TO BE PROBABLY RELATED TO BIOTENE ORAL BALANCE GEL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE FOREIGN BODY IN RESPIRATORY TRACT TO BE RELATED TO BIOTENE ORAL BALANCE GEL. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A WHOLESALER EMPLOYEE, WHO RECEIVED THIS CASE FROM A HOSPITAL. ON (B)(6) 2018 THE PATIENT NEARLY SUFFOCATED DUE TO BIOTENE ORAL BALANCE GEL, THE GEL ENTERED THE LUNGS OF THE PATIENT. THE FOLLOWING BATCH NUMBERS WERE RETURNED TO THE WHOLESALER BY THE HOSPITAL: 101199, 5144526 (EXPIRY DATE: APR-2020), 5144966 (EXPIRY DATE: AUG-2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227903 BIOTENE ORAL BALANCE GEL ORAL GEL LFD ULTRADENT PRODUCTS INC/ORATECH LLC 5144526

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O