MAUDE Adverse Event Report: INHALER; NASAL SPRAY, ENT DELIVERY

Lot Number 62003454

Device Problem No Flow (2991)

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

Event Date 06/10/2023

Event Type  malfunction  

Event Description

Reporter called to report that the inhaler is not dispensing the medication because it is defective.She said she picked up another one yesterday, and that is not working either.She said she has two defective inhalers in her possession now.Ref report #mw5119189.

• Brand Name: INHALER
• Type of Device: NASAL SPRAY, ENT DELIVERY
• MDR Report Key: 17280967
• MDR Text Key: 318705801
• Report Number: MW5119188
• Device Sequence Number: 1
• Product Code: KCO
• 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: 07/06/2023

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
• Device Expiration Date: 04/01/2024
• Device Lot Number: 62003454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1
• Treatment: WIXELA
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 48 KG