MAUDE Adverse Event Report: UNKNOWN AEROSOL INHALER HFA 200MG; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Failure to Deliver (2338); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Reporter called and stated that he has been having issues while trying to use his aerosol inhaler.Reporter stated machine shows 130 doses left and when he shakes the inhaler it sounds like medication is left but while trying to use, no medication comes out.This has been an ongoing problem for two weeks.Reporter unable to provide name of company.No adverse events.

• Brand Name: AEROSOL INHALER HFA 200MG
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16042927
• MDR Text Key: 306247570
• Report Number: MW5113955
• 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: Patient
• Type of Report: Initial
• Report Date: 12/21/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Patient Sequence Number: 1
• Patient Sex: Male