BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE

    MDR report key: 6816707 · Received August 24, 2017

    Report

    Report Number
    1718912-2017-00024
    Event Type
    Injury
    Date Received
    August 24, 2017
    Report Date
    August 16, 2017
    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

    1718912-2017-00024 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND DRY MOUTH. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND DRY MOUTH WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO BIOTENE. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DRY MOUTH TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 16 AUGUST 2017. CONSUMER REPORTED USING BIOTENE. THE CONSUMER REPORTED THIS WAS THE FIRST TIME SHE PURCHASED THE PRODUCT AND IT WAS OVERWHELMING SWEET TO HER. IT WAS CHOKING HER. HER PROBLEM SEEMED TO FURTHER DOWN IN HER THROAT AND JUST IN HER MOUTH, THE DRYNESS. THE AFTER EFFECT WAS CHOKING HER. SHE RINSED IT OUT AS QUICKLY AS SHE COULD. FOLLOW-UP INFORMATION WAS RECEIVED ON 13 OCTOBER 2017 VIA RETURNED CONSUMER AUTHORIZATION FORM. THE CONSUMER STATED, "PLEASE REMOVE THIS CASE. AFTER BEING ON HOLD FOR APPROXIMATELY FOR 20 MINUTES, THIS IS NOT A VALID CONCERN. PRODUCT WAS JUST TOO SWEET. WHEN I CALLED ORIGINALLY, YOUR AGENT SUGGESTED THAT I TAKE IT BACK TO THE STORE TO AVOID THIS TYPE OF THING. I DID. END OF STORY". THE CONSUMER DENIED TO FURTHER FOLLOW UP AND DID NOT PROVIDE HEALTHCARE PROVIDER DETAILS.

    Description of Event or Problem · 1

    IT WAS CHOKING HER, AFTER EFFECT WAS CHOKING HER, PROBLEM SEEMS TO FURTHER DOWN IN HER THROAT [CHOKING]. JUST IN HER MOUTH, THE DRYNESS [DRY MOUTH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A FEMALE PATIENT WHO RECEIVED BIOTENE ORALBALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND DRY MOUTH. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND DRY MOUTH WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING TO BE RELATED TO BIOTENE. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DRY MOUTH TO BE RELATED TO BIOTENE. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 16 AUGUST 2017. CONSUMER REPORTED USING BIOTENE. THE CONSUMER REPORTED THIS WAS THE FIRST TIME SHE PURCHASED THE PRODUCT AND IT WAS OVERWHELMING SWEET TO HER. IT WAS CHOKING HER. HER PROBLEM SEEMED TO FURTHER DOWN IN HER THROAT AND JUST IN HER MOUTH, THE DRYNESS. THE AFTER EFFECT WAS CHOKING HER. SHE RINSED IT OUT AS QUICKLY AS SHE COULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596027 BIOTENE UNKNOWN LFD ULTRADENT PRODUCTS INC./ ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other