MAUDE Adverse Event Report: NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

Event Type  Injury  

Event Description

Reporter's albuterol inhaler plunger will not work after twenty puffs.The doctor tried to prescribe additional inhalers however, the insurance will not cover the cost.

• Brand Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 12392347
• MDR Text Key: 269422615
• Report Number: MW5103615
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100