BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)

    MDR report key: 8184074 · Received December 20, 2018

    Report

    Report Number
    9615332-2018-00187
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    December 18, 2018
    Manufacturer
    KIK CUSTOM PRODUCTS
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9615332-2018-00187 IS ASSOCIATED WITH ARGUS CASE (B)(6), BIOTENE ORIGINAL ORAL RINSE (ORIGINAL).

    Description of Event or Problem · 1

    I DRANK A LITTLE BIT. [ACCIDENTAL DEVICE INGESTION]. IT SAYS DO NOT USE IF SHRINK SLEEVE IS MISSING OR BROKEN. WHAT DOES THAT MEAN? IT'S MISSING. I DRANK A LITTLE BIT [DEVICE USE ERROR]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER 8H133C, EXPIRY DATE 13TH JULY 2021) FOR DRY MOUTH. ON (B)(6) 2018, THE PATIENT STARTED BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORIGINAL ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND DEVICE USE ERROR. THE ACTION TAKEN WITH BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND DEVICE USE ERROR WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION AND DEVICE USE ERROR TO BE RELATED TO BIOTENE ORIGINAL ORAL RINSE (ORIGINAL). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL ON (B)(6) 2018. THE CONSUMER REPORTED THAT "I JUST PICKED A BOTTLE OF BIOTENE FOR THE FIRST TIME AND IT SAYS DO NOT USE IF SHRINK SLEEVE IS MISSING OR BROKEN. WHAT DOES THAT MEAN? IT'S MISSING. I DRANK A LITTLE BIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026074 BIOTENE ORIGINAL ORAL RINSE (ORIGINAL) ORAL RINSES LFD KIK CUSTOM PRODUCTS 8H133C

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other