BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (ORIGINAL)

    MDR report key: 13117767 · Received December 30, 2021

    Report

    Report Number
    3012293198-2021-00082
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 21, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    I GOT I STARTED CHOKING [CHOKING]. WHEN IS SWALLOWED [ACCIDENTAL DEVICE INGESTION]. COUGHING [COUGH]. MY THROAT HAD THIS TICKLE [THROAT IRRITATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF CHOKING IN A (B)(6) FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER U1HO61, EXPIRY DATE 30TH JULY 2024) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON (B)(6) 2021, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), COUGH AND THROAT IRRITATION. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING AND ACCIDENTAL DEVICE INGESTION WERE UNKNOWN AND THE OUTCOME OF THE COUGH WAS RECOVERING/RESOLVING AND THE OUTCOME OF THE THROAT IRRITATION WAS NOT RECOVERED/NOT RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE CHOKING, ACCIDENTAL DEVICE INGESTION, COUGH AND THROAT IRRITATION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADDITIONAL DETAILS : THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 21DEC2021. THE CONSUMER STATED THAT, "MY BIRTH DATE IS. THIS MORNING I SPRAY MY TONGUE WITH BIOTENE SPRAY BECAUSE MY TONGUE HAS BEEN VERY DRY AND MOUTH. FOR SOME REASON WHEN IS SWALLOWED I GOT I STARTED CHOKING, COUGHING WHICH TURNED INTO A CHOKE IT WAS LIKE THE RIGHT HAND SIDE OF MY THROAT HAD THIS TICKLE AND WOULDN'T GO AWAY AND STARTED AROUND 10 O'CLOCK THIS MORNING AND STILL HAVING ISSUES. IS THERE ANYTHING I CAN DO TO GET RID OF THAT TICKLE AND BE ABLE TO JUST RELAX? ITS STARTING TO EASY BUT IT WONT STOP IF YOU COULD CALL ME AT YOUR EARLIEST CONVENIENCE I WOULD APPRECIATE IT." FOLLOW UP INFORMATION RECEIVED FROM A CONSUMER VIA CALL CENTER REPRESENTATIVE (PHONE) ON 21DEC2021. THE CONSUMER STATED THAT, "I CANT REALLY HEAR YOU CLEARLY. LET ME ASK YOU MY QUESTION AND JUST ANSWER ME BRIEFLY. I'M TRYING TO USE BIOTENE SPRAY AND SOME GOT INSIDE MY THROAT AND STARTED TO TICKLE AND THEN BECAME A COUGH. NOW THE COUGH LESSEN BUT THE TICKLE IS STILL THERE. LOT U1HO61 EXP 20240730. I DID TRY TO TALK TO A PHARMACIST ALREADY BUT THEY DIDN'T RECOMMEND ANY." INITIAL AND FOLLOW UP INFORMATION WERE PROCESSED TOGETHER. (B)(4) HAS BEEN IDENTIFIED AS DUPLICATE OF (B)(4). ALL FUTURE CORRESPONDENCE WILL BE SUBMITTED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020237 BIOTENE MOUTH SPRAY (ORIGINAL) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC U1HO61

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other