BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE GEL

    MDR report key: 8208792 · Received January 2, 2019

    Report

    Report Number
    3012293198-2018-00016
    Event Type
    Injury
    Date Received
    January 2, 2019
    Report Date
    December 20, 2018
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 3012293198-2018-00016 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE GEL.

    Description of Event or Problem · 1

    UNCONSCIOUS. A THICK GEL FORMED AT BACK OF HIS MOUTH (ORAL DISORDER). THICK GEL FORMED AT BACK OF MOUTH MAKING HIM DIFFICULT TO BREATH (DIFFICULTY BREATHING). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A OTHER HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF UNCONSCIOUS IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE GEL) GEL FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE GEL. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE GEL, THE PATIENT EXPERIENCED UNCONSCIOUS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ORAL DISORDER AND DIFFICULTY BREATHING. THE PATIENT WAS TREATED WITH OXYGEN (OXYGEN THERAPY). THE ACTION TAKEN WITH BIOTENE GEL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE UNCONSCIOUS, ORAL DISORDER AND DIFFICULTY BREATHING WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNCONSCIOUS, ORAL DISORDER AND DIFFICULTY BREATHING TO BE RELATED TO BIOTENE 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: THE HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT EXPERIENCED THE ADVERSE EVENTS WITH BIOTENE GEL. THE PATIENT USED THE BIOTENE GEL, HE WAS UNCONSCIOUS AND WAS ON OXYGEN. THERE WAS A THICK GEL FORMED AT THE BACK OF HIS MOUTH WHICH MADE HIM VERY DIFFICULT TO BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3642 BIOTENE GEL UNKNOWN LFD ULTRADENT PRODUCTS INC/ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other