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

Model Number CFC90MCT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

Reporter called to report that her inhaler stopped working.

• Brand Name: SANDOZ INHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 12648943
• MDR Text Key: 277366114
• Report Number: MW5104683
• Device Sequence Number: 1
• Product Code: CAF
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CFC90MCT
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 77