MAUDE Adverse Event Report: INHALER; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient called to report a defective inhaler.She stated inhaler stopped working after using a few times and stopped being effective.

• Brand Name: INHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 17863063
• MDR Text Key: 324878289
• Report Number: MW5146465
• 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: Patient
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Sex: Female