BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORAL BALANCE GEL (AROMA)

    MDR report key: 11805338 · Received May 11, 2021

    Report

    Report Number
    3012293198-2021-00029
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    April 13, 2021
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    IM ADDICTED TO IT. I AM ADDICTED TO 9 DIFFERENT TYPES OF DRUGS. [ADDICTION]. I ALSO USE THE BIOTENE ORAL RINSE BUT IT DOES NOT WORK, ITS NOT GOOD FOR OVERNIGHT RELIEF. (EXPIRED PRODUCT) [LACK OF DRUG EFFECT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ADDICTION IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL BALANCE GEL (AROMA)) GEL (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 5H06C1, EXPIRY DATE 31ST JULY 2018) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL BALANCE GEL (AROMA) AND BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED ADDICTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), LACK OF DRUG EFFECT AND EXPIRED DRUG ADMINISTERED. THE ACTION TAKEN WITH BIOTENE ORAL BALANCE GEL (AROMA) WAS UNKNOWN. THE ACTION TAKEN WITH BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ADDICTION, LACK OF DRUG EFFECT AND EXPIRED DRUG ADMINISTERED WERE UNKNOWN. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ON 13 APR 2021, CONSUMER STATED THAT "I HAVE BEEN USING BIOTENE GEL FOR YEARS AND IT WORKS WELL, BUT I CANNOT FIND IT. IM HAVING TROUBLE SLEEPING BECAUSE OF DRY MOUTH, IM ADDICTED TO IT. I AM ADDICTED TO 9 DIFFERENT TYPES OF DRUGS. I ALSO USE THE BIOTENE ORAL RINSE BUT IT DOES NOT WORK, ITS NOT GOOD FOR OVERNIGHT RELIEF." CONSUMER WAS NOT AWARE HE IS USING AN EXPIRED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705077 BIOTENE ORAL BALANCE GEL (AROMA) ORAL GEL LFD ULTRADENT PRODUCTS INC/ORATECH LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR