BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION, USP, 3% 4ML

    MDR report key: 21371205 · Received February 13, 2025

    Report

    Report Number
    3001237796-2025-00010
    Event Type
    Injury
    Date Received
    February 13, 2025
    Report Date
    February 13, 2025
    Manufacturer
    THE RITEDOSE CORPORATION
    Product Code
    CAF
    UDI-DI
    00376204022606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A 61-YEAR-OLD FEMALE PATIENT WHO EXPERIENCED REPETITIVE STREPTOCOCCUS IN THE LUNGS, SKIN BREAK OUT FROM CHEST, ALWAYS ITCH AFTER SODIUM CHLORIDE TREATMENT/ITCHING, REPETITIVE THRUSH, AND BACTERIAL INFECTION IN THE MOUTH COINCIDENT WITH SODIUM CHLORIDE INHALATION SOLUTION 3%. IN (B)(6) 2024 (UNKNOWN EXACT DATE), THE PATIENT INITIATED THE SODIUM CHLORIDE INHALATION SOLUTION FOR COLLAPSED LUNGS. IT WAS REPORTED THAT SHE WAS ORIGINALLY ON SODIUM CHLORIDE INHALATION SOLUTION 3% BUT WAS GIVEN 7% DUE TO THE MEDICATION BEING OUT OF STOCK FOR A WEEK. IMMEDIATELY AFTER STARTING SODIUM CHLORIDE INHALATION SOLUTION, THE PATIENT EXPERIENCED A SKIN BREAKOUT OUT FROM THE CHEST AND ITCHING. SHE MENTIONED THAT SHE ALWAYS EXPERIENCED ITCH AFTER SODIUM CHLORIDE TREATMENT. THE PATIENT WAS ALSO PLACED ON POSACONAZOLE FOR ONLY THREE MONTHS STARTING FROM (B)(6) 2024. THE PATIENT STATED THAT SHORTLY AFTER STARTING THE MEDICATION, SHE WAS GETTING REPETITIVE STREPTOCOCCUS IN THE LUNGS AND HAD BEEN HOSPITALIZED (UNKNOWN DATE) AND RECEIVED INTRAVENOUS ANTIBIOTICS AS TREATMENT (DATE UNKNOWN). IN (B)(6) 2024, THE PATIENT STATED THAT SHE STARTED EXPERIENCING REPETITIVE THRUSH AND BACTERIAL INFECTIONS IN THE MOUTH. IN (B)(6) 2024 (PAST MONTH, EXACT DATE UNKNOWN), THE PATIENT'S DOSE OF SODIUM CHLORIDE INHALATION SOLUTION WAS REDUCED TO 0.9% DUE TO THE SKIN BREAKOUTS, AND SHE WAS IMPROVING BUT STILL HAD SOME ISSUES, ALTHOUGH NOT AS CHRONIC. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION 3% WAS DOSE DECREASED. THE OUTCOME OF THE EVENT SKIN BREAK OUT FROM CHEST WAS RESOLVING. THE OUTCOME OF THE EVENTS REPETITIVE STREPTOCOCCUS IN THE LUNGS, ALWAYS ITCH AFTER SODIUM CHLORIDE TREATMENT/ITCHING, REPETITIVE THRUSH, AND BACTERIAL INFECTION IN THE MOUTH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126538 SODIUM CHLORIDE INHALATION SOLUTION, USP, 3% 4ML NEBULIZER (DIRECT PATIENT INTERFACE) CAF THE RITEDOSE CORPORATION 00376204022606

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization CHOLESTEROL MEDICATION| POSACONAZOLE (B)(6)2024)