MAUDE Adverse Event Report: AEROCHAMBER PLUS WITH MASK- MEDIUM; HOLDING CHAMBERS, DIRECT PATIENT INTERFACE.

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patients mother (b)(6) reported patient was hospitalized to cystic tune up first fill with (b)(6) delivery scheduled (b)(6) 2022.Prescriber contact information: (b)(6).

• Brand Name: AEROCHAMBER PLUS WITH MASK- MEDIUM
• Type of Device: HOLDING CHAMBERS, DIRECT PATIENT INTERFACE.
• MDR Report Key: 13798865
• MDR Text Key: 287576456
• Report Number: MW5108225
• Device Sequence Number: 1
• Product Code: NVP
• 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: 03/14/2022

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?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female