MAUDE Adverse Event Report: THE RITEDOSE CORPORATION SODIUM CHLORIDE INHALATION SOLUTION, USP, 3% 4ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Itching Sensation (1943); Rash (2033); Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION, USP, 3% 4ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): THE RITEDOSE CORPORATION; director of regulatory affairs; 1 technology circle; columbia SC 29203
• Manufacturer (Section G): THE RITEDOSE CORPORATION; director of regulatory affairs; 1 technology circle; colombia SC 29203
• Manufacturer Contact: arianne lindsey ; director of regulatory affairs; 1 technology circle; colombia, SC 29203 ; 8039354114
• MDR Report Key: 21371205
• Report Number: 3001237796-2025-00010
• Device Sequence Number: 18292317
• Product Code: CAF
• UDI-Device Identifier: 00376204022606
• UDI-Public: 00376204022606
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/13/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/13/2025
• 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: CHOLESTEROL MEDICATION; POSACONAZOLE (B)(6)2024)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female