BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE PBF ORAL RINSE (ORIGINAL)

    MDR report key: 10741816 · Received October 27, 2020

    Report

    Report Number
    3012293198-2020-00095
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 12, 2020
    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

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    I LIFTED MY HEAD AND FOR SOME REASON I SWALLOWED A BIT OF IT. I HAVE BEEN CHOKING FOR AN HOUR. [ACCIDENTAL DEVICE INGESTION]. I LIFTED MY HEAD AND FOR SOME REASON I SWALLOWED A BIT OF IT. I HAVE BEEN CHOKING FOR AN HOUR. [CHOKING]. IM STILL CHOKING AND COUGHING [COUGH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE PBF ORAL RINSE (ORIGINAL)) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR ORAL HYGIENE. ON (B)(6) 2020, THE PATIENT STARTED BIOTENE PBF ORAL RINSE (ORIGINAL). ON (B)(6) 2020, LESS THAN A DAY AFTER STARTING BIOTENE PBF ORAL RINSE (ORIGINAL), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND COUGH. BIOTENE PBF ORAL RINSE (ORIGINAL) WAS DISCONTINUED ON (B)(6) 2020 (DECHALLENGE WAS NEGATIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN AND THE OUTCOME OF THE CHOKING AND COUGH WERE NOT RECOVERED/NOT RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION, CHOKING AND COUGH TO BE RELATED TO BIOTENE PBF 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 DETAILS, ADVERSE EVENT INFORMATION RECEIVED VIA CALL CENTER REPRESENTATIVE ON 12 OCTOBER 2020. THE CONSUMER REPORTED, "BIOTENE MOUTH WASH COOL MINT THE BIGGEST ONE. I DON'T HAVE IT FRONT OF ME. I TRIED IT FOR THE FIRST TIME I'VE NEVER DONE THIS WITH MOUTH WASH. I LIFTED MY HEAD AND FOR SOME REASON I SWALLOWED A BIT OF IT. I KNOW YOU ARE NOT SUPPOSE TO SWALLOW MOUTHWASH. I HAVE BEEN CHOKING FOR AN HOUR. I WAS WONDERING IF YOU COULD SUGGEST SOMETHING. IT'S GOT TO BE MUCH OUNCE. IT HAD TO BE A TINY AMOUNT. YOU KNOW THOSE I GARGLED WITH IT, IT WAS 1/4 FULL, I COULDN'T HAVE SWALLOWED THAT MUCH. I ATE 2 PIECES OF BREAD AND DRANK TWO SMALL BOTTLES OF WATER AND I'M STILL CHOKING AND COUGHING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205983 BIOTENE PBF ORAL RINSE (ORIGINAL) ORAL RINSES LFD KIK CUSTOM PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other