BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE GEL

    MDR report key: 7046496 · Received November 20, 2017

    Report

    Report Number
    1718912-2017-00029
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    November 9, 2017
    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
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    1718912-2017-00029 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE GEL.

    Description of Event or Problem · 1

    STROKE [STROKE]. DIFFICULTY SWALLOWING [SWALLOWING DIFFICULT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF STROKE IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE GEL) GEL FOR DRUG USE 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 STROKE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SWALLOWING DIFFICULT. THE ACTION TAKEN WITH BIOTENE GEL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE STROKE AND SWALLOWING DIFFICULT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE STROKE AND SWALLOWING DIFFICULT TO BE RELATED TO BIOTENE GEL. ADDITIONAL INFORMATION: IT WAS REPORTED: "MY RELATIVE WHO IS A STROKE PATIENT USED BIOTENE ORAL GEL. MY RELATIVE HAS DIFFICULTY SWALLOWING AND THE HYGIENIST ADVISE HIM NOT TO USE THE PRODUCT."

    Description of Event or Problem · 1

    NO ADVERSE EVENT (CONFIRMED EVENTS OCCURRED BEFORE TAKING PRODUCT) [NO ADVERSE EVENT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF STROKE IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE GEL) GEL FOR DRUG USE 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 STROKE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SWALLOWING DIFFICULT. THE ACTION TAKEN WITH BIOTENE GEL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE STROKE AND SWALLOWING DIFFICULT WERE NOT REPORTED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE STROKE AND SWALLOWING DIFFICULT TO BE RELATED TO BIOTENE GEL. ADDITIONAL INFORMATION: IT WAS REPORTED: "MY RELATIVE WHO IS A STROKE PATIENT USED BIOTENE ORAL GEL. MY RELATIVE HAS DIFFICULTY SWALLOWING AND THE HYGIENIST ADVISE HIM NOT TO USE THE PRODUCT." FOLLOW UP RECEIVED ON 21-NOV-2017: IT WAS REPORTED "THE PATIENT HAD A STROKE RESULTING IN A SWALLOWING DIFFICULTY BEFORE USING BIOTENE ORAL BALANCE GEL AND AND AFTER THE STROKE WAS ALSO SUFFERING FROM A DRY MOUTH - HENCE MY RECOMMENDATION TO USE IT. THIS WAS COUNTER INSTRUCTED BY A MEMBER OF THE NURSING STAFF WHO SAID THE PRODUCT WOULD STIMULATE SALIVARY FLOW. " THE REPORTER CONFIRMED THAT STROKE AND SWALLOWING DIFFICULTY DEVELOPED BEFORE USING BIOTENE ORAL BALANCE GEL. THEREFORE THE CASE WILL BE DELETED AS IT HAS BEEN CONFIRMED THE EVENTS OCCURRED BEFORE USING BIOTENE ORAL BALANCE GEL. COMMENT: DOWNGRADE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826864 BIOTENE GEL ORAL GEL LFD ULTRADENT PRODUCTS INC./ ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other