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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

Event: pt currently hospitalized for respiratory issues and dr is aware.Inhale 4 ml via nebulizer two times a day, may increase up to four times daily as needed for increased cough.

• Brand Name: NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 13549664
• MDR Text Key: 285835011
• Report Number: MW5107549
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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
• Treatment: AQUADEKS ORO; COMPLETE FORMULATION PEDI; FLOVENT DISK AER 100 MCG; NEBUSAL; PULMOSAL 7% 4 ML/NEB 240=60 ; QVAR AER 80 MCG; RANITIDINE TAB 150 MG; VENTOLIN HFA; ZENPEP CAP 5000 UNIT
• Patient Outcome(s): Hospitalization
• Patient Sex: Male