MAUDE Adverse Event Report: THE RITEDOSE CORPORATION SODIUM CHLORIDE INHALATION SOLUTION, USP, 7% 4 ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	NOT AVAIL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION, USP, 7% 4 ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): THE RITEDOSE CORPORATION; 1 technology circle; columbia 29203
• Manufacturer (Section G): THE RITEDOSE CORPORATION; 1 technology circle; columbia SC 29203
• Manufacturer Contact: arianne lindsey ; 1 technology circle; columbia, SC 29203
• MDR Report Key: 22024472
• Report Number: 3001237796-2025-00059
• Device Sequence Number: 18423297
• Product Code: CAF
• UDI-Device Identifier: 00376204021609
• UDI-Public: 00376204021609
• Combination Product (Y/N): N
• 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): 05/15/2025

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 Model Number: NOT AVAIL
• Device Catalogue Number: NOT AVAIL
• Device Lot Number: NOT AVAIL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/15/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female