BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION, USP, 7% 4 ML

    MDR report key: 22024472 · Received May 15, 2025

    Report

    Report Number
    3001237796-2025-00059
    Event Type
    Injury
    Date Received
    May 15, 2025
    Report Date
    May 15, 2025
    Manufacturer
    THE RITEDOSE CORPORATION
    Product Code
    CAF
    UDI-DI
    00376204021609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY A FEMALE PATIENT (UNSPECIFIED AGE) WHO WAS HOSPITALIZED FOR 3 DAYS TO RECEIVE IV ANTIBIOTICS, HAVING A HARD TIME TOLERATING THE SODIUM CHLORIDE INHALATION SOLUTION 7%. ON AN UNSPECIFIED DATE IN (B)(6) 2025, THE PATIENT-INITIATED TREATMENT WITH SODIUM CHLORIDE INHALATION SOLUTION, USP, 7%, (UNSPECIFIED DOSING DETAILS) TO TREAT REGARDING A MICRO-ORGANISM FOUND IN HER LUNGS. SHE REPORTED THAT SHE HAD HARD TIME TO TOLERATE SODIUM CHLORIDE INHALATION SOLUTION 7%. ON AN UNSPECIFIED DATE SHE WAS HOSPITALIZED FOR 3 DAYS AND RECEIVED INTRAVENOUS (IV) ANTIBIOTICS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION AND THE OUTCOME OF THE EVENTS WAS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826675 SODIUM CHLORIDE INHALATION SOLUTION, USP, 7% 4 ML NEBULIZER (DIRECT PATIENT INTERFACE) CAF THE RITEDOSE CORPORATION NOT AVAIL NOT AVAIL 00376204021609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization