MAUDE Adverse Event Report: UNKNOWN VENTOLIN-ALBUTEROL HFA 90MCG; NEBULIZER (DIRECT PATIENT INTERFACE)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2024

Event Type  Injury  

Event Description

Reporter called to advise the fda that in the past two months, when receiving an inhaler for her patient, after approximately one week of use, the inhaler stops working but indicates that it still has enough albuterol for the rest of the month.This has happened twice now, and it cannot be replaced until the one-month time has passed.Her patient is an elderly woman who suffers from chronic obstructive pulmonary disease (copd) and needs this device to work on a daily basis so that she can breathe.Reference report: mw5153606.

• Brand Name: VENTOLIN-ALBUTEROL HFA 90MCG
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19059088
• MDR Text Key: 339701364
• Report Number: MW5153607
• 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: Personal Care Assistant
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female