BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 15ML

    MDR report key: 22095307 · Received May 28, 2025

    Report

    Report Number
    3001237796-2025-00057
    Event Type
    Injury
    Date Received
    May 28, 2025
    Report Date
    May 28, 2025
    Manufacturer
    THE RITEDOSE CORPORATION
    Product Code
    CAF
    UDI-DI
    00376204300506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 USED SODIUM CHLORIDE INHALATION SOLUTION 0.9% FOR HER SCLERAL LENS AND ACANTHAMOEBA. IN AN UNSPECIFIED DATE IN 2022-2023, THE PATIENT-INITIATED TREATMENT WITH SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% (UNSPECIFIED DOSING DETAILS) VIA THE OPHTHALMIC ROUTE FOR SCLERAL LENS. ON AN UNSPECIFIED DATE IN 2024, THE PATIENT HAD ACANTHAMOEBA PARASITE IN THE RIGHT EYE FOLLOWING SHE HAD EVISCERATION OF RIGHT EYE ON (B)(6) 2024. SHE STATED THAT SHE HAS STOPPED USING HER LENSES SINCE (B)(6) 2024. ACTION TAKEN WITH SODIUM CHLORIDE INHALATION SOLUTION WAS UNKNOWN. THE OUTCOME OF THE EVENT ACANTHAMOEBA WAS UNKNOWN. THE OUTCOME OF THE EVENT USING SODIUM CHLORIDE INHALATION SOLUTION 0.9% FOR HER SCLERAL LENS WHICH SHE GOT THROUGH DOCTOR'S PRESCRIPTION WAS NOT APPLICABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 30-APR-2025: EVENT OF MISUSE UPDATED TO OFF LABEL, ADDITIONAL EVENT (ACANTHAMOEBA PARASITE IN THE RIGHT EYE), THERAPY START DATE, MEDICAL HISTORY, CONCOMITANT MEDICATIONS ADDED, AND EVENT DESCRIPTION UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715251 SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 15ML NEBULIZER (DIRECT PATIENT INTERFACE) CAF THE RITEDOSE CORPORATION 24AD9 00376204300506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other CALCIUM.| FORTEO (TERIPARATIDE).| FOSAMAX (ALENDRONATE SODIUM).| VITAMIN D3.