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

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

A reporter called to report that her inhaler for her albuterol is not working.She said only air is coming out but not the medication.She said, she has 3 of them all together and none of them are working.Reference report #mw5117625, #mw5117627.

• Brand Name: INHALER
• Type of Device: NASAL SPRAY, ENT DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16952882
• MDR Text Key: 315575308
• Report Number: MW5117626
• 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: 05/17/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG