MAUDE Adverse Event Report: SOD CHL 7% 4ML 4=1 NEB; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Pt passed away.Inhale 3 ml twice daily via nebulizer.

• Brand Name: SOD CHL 7% 4ML 4=1 NEB
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 18274240
• MDR Text Key: 329869050
• Report Number: MW5148842
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female