MAUDE Adverse Event Report: THE RITEDOSE CORPORATION SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 15ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Lot Number	24AD9
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Infective Keratitis (1945)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION, USP, 0.9% 15ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): THE RITEDOSE CORPORATION; 1 technology circle; columbia SC 29203
• Manufacturer (Section G): THE RITEDOSE CORPORATION; 1 technology circle; columbia, SC 29203
• Manufacturer Contact: arianne lindsey ; 1 technology circle; columbia, SC 29203 ; 8039354114
• MDR Report Key: 22095307
• Report Number: 3001237796-2025-00057
• Device Sequence Number: 8022652
• Product Code: CAF
• UDI-Device Identifier: 00376204300506
• UDI-Public: 00376204300506
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2026
• Device Lot Number: 24AD9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CALCIUM.; FORTEO (TERIPARATIDE).; FOSAMAX (ALENDRONATE SODIUM).; VITAMIN D3.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female