MAUDE Adverse Event Report: INTAKE BREATHING TECHNOLOGY LLC. INTAKE NASAL STRIP; DILATOR, NASAL

Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Wore the nose band as directed, and had skin irritation and developed a rash.

• Brand Name: INTAKE NASAL STRIP
• Common Device Name: DILATOR, NASAL
• Manufacturer (Section D): INTAKE BREATHING TECHNOLOGY LLC.
• MDR Report Key: 20845145
• Report Number: MW5163141
• Device Sequence Number: 17125679
• Product Code: LWF
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male