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

Lot Number 204997A

Device Problems Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

A reporter called to report that his copd inhaler does not work for the past 7 months.He said he uses 1 inhaler per month, all 7 of them haven't been working as intended.He said they have mechanical problems as a result the measurement is inaccurate.He said since the medication is mist, odorless and test less, it is difficult to know if he is getting the prescribed dose.Reference report #mw5117900, #mw5117901, #mw5117902, #mw5117903, #mw5117905, #mw5117906.

• Brand Name: INHALER
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17010308
• MDR Text Key: 316152933
• Report Number: MW5117904
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 204997A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: STIOLTO RESPIMAT, 2.5 MCG.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG