BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION 0.9%

    MDR report key: 18168065 · Received November 20, 2023

    Report

    Report Number
    3001237796-2023-00128
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    September 9, 2022
    Report Date
    November 20, 2023
    Manufacturer
    THE RITEDOSE CORPORATION
    Product Code
    CAF
    UDI-DI
    00376204300506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AND CONCERNS A 75-YEAR-OLD FEMALE, WHO EXPERIENCED SWELLING OF LIPS AND TONGUE, FLUSHED RED FACE/FACE RED, ALLERGIC REACTION TO NEBULIZER SOLUTION AND SOB (SHORTNESS OF BREATH) COINCIDENT WITH SODIUM CHLORIDE INHALATION SOLUTION (B)(4). ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED FOR VOCAL CORD REPAIR SURGERY DUE TO VOCAL CORD PARALYSIS AND THEY ACCIDENTALLY LACERATED HER OESOPHAGUS. DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS (IV) MEDICATION AT THE HOSPITAL THAT INCLUDED IV ANCEF CONTINUOUSLY FOR 24-48 HOURS, IV IBUPROFEN AND IV TYLENOL POST-SURGERY. ON THE SAME DAY AFTER THE SURGERY, THE PATIENT-INITIATED SODIUM CHLORIDE INHALATION SOLUTION (B)(4) VIA NEBULIZER AND FACE MASK OVER THE NEXT FOUR DAYS. THE PATIENT ALSO RECEIVED LIQUID IBUPROFEN BEFORE GOING HOME. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE PATIENT HAD ANOTHER BREATHING TREATMENT OF (B)(4) WITH SODIUM CHLORIDE INHALATION SOLUTION. AFTER THE TREATMENT, SHE HAD AN ALLERGIC REACTION. THE PATIENT'S SYMPTOMS INCLUDED FACE BEING FLUSHED RED, SWELLING OF LIPS AND TONGUE. THE PATIENT HAD SOB. SHE TOOK BENADRYL (DIPHENHYDRAMINE) AT HOME BUT HAD NO CHANGE. ON (B)(6) 2022, SHE VISITED THE EMERGENCY ROOM AND WAS TREATED WITH AN INJECTION OF 10 MG OF DEXAMETHASONE. SHE REMAINED IN THE EMERGENCY ROOM (ER) UNTIL HER SYMPTOMS IMPROVED. SHE CONSULTED THE DOCTORS AND PHARMACIST AND THEY THOUGHT SHE HAD A REACTION TO THE PRESERVATIVE IN THE SODIUM CHLORIDE INHALATION SOLUTION (B)(4), WHICH SHE LATER CONFIRMED TO BE AN ALLERGIC REACTION TO THE NEBULIZER SOLUTION. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION (B)(4) WAS NOT APPLICABLE. OUTCOME OF THE EVENTS WAS RECOVERING. ADDITIONAL INFORMATION RECEIVED ON 14-NOV-2023: PROVIDED THERAPY DATES, ER VISIT DATE, EVENT DETAILS, THERAPY DETAILS AND EVENTS OUTCOME. UPDATED EVENT VERBATIM FOR ALLERGIC REACTION TO ALLERGIC REACTION TO NEBULIZER SOLUTION, WHICH WAS PREVIOUSLY ATTRIBUTED TO A PRESERVATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598747 SODIUM CHLORIDE INHALATION SOLUTION 0.9% NEBULIZER (DIRECT PATIENT INTERFACE) CAF THE RITEDOSE CORPORATION 00376204300506

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other ANCEF (CEFAZOLIN SODIUM).| IBUPROFEN.| TYLENOL (PARACETAMOL).