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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Hot Flashes/Flushes (2153); Decreased Respiratory Rate (2485); Swelling/ Edema (4577)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report from the united states was reported by a consumer and concerns a 75-year-old female, who experienced swelling of lips and tongue, flushed red face/face red, allergic reaction to nebulizer solution and sob (shortness of breath) coincident with sodium chloride inhalation solution (b)(4).On (b)(6) 2023, the patient was hospitalized for vocal cord repair surgery due to vocal cord paralysis and they accidentally lacerated her oesophagus.During hospitalization, the patient received intravenous (iv) medication at the hospital that included iv ancef continuously for 24-48 hours, iv ibuprofen and iv tylenol post-surgery.On the same day after the surgery, the patient-initiated sodium chloride inhalation solution (b)(4) via nebulizer and face mask over the next four days.The patient also received liquid ibuprofen before going home.On (b)(6) 2022, the patient was discharged from hospital.The patient had another breathing treatment of (b)(4) with sodium chloride inhalation solution.After the treatment, she had an allergic reaction.The patient's symptoms included face being flushed red, swelling of lips and tongue.The patient had sob.She took benadryl (diphenhydramine) at home but had no change.On (b)(6) 2022, she visited the emergency room and was treated with an injection of 10 mg of dexamethasone.She remained in the emergency room (er) until her symptoms improved.She consulted the doctors and pharmacist and they thought she had a reaction to the preservative in the sodium chloride inhalation solution (b)(4), which she later confirmed to be an allergic reaction to the nebulizer solution.Action taken with sodium chloride inhalation solution (b)(4) was not applicable.Outcome of the events was recovering.Additional information received on 14-nov-2023: provided therapy dates, er visit date, event details, therapy details and events outcome.Updated event verbatim for allergic reaction to allergic reaction to nebulizer solution, which was previously attributed to a preservative.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION 0.9%
• 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; columbia SC 29203
• Manufacturer Contact: arianne lindsey ; director of regulatory affairs; 1 technology circle; columbia, SC 29203 ; 8039354114
• MDR Report Key: 18168065
• Report Number: 3001237796-2023-00128
• Device Sequence Number: 6613198
• Product Code: CAF
• UDI-Device Identifier: 00376204300506
• UDI-Public: 00376204300506
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: 10/31/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ANCEF (CEFAZOLIN SODIUM).; IBUPROFEN.; TYLENOL (PARACETAMOL).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female