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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/14/2020

Event Type  malfunction  

Event Description

Reporter stated that her inhaler works sometimes and sometimes it does not work.She said so far she had the same issues with her 4 inhalers.

• Brand Name: INHALER
• Type of Device: NASAL SPRAY, ENT DELIVERY
• MDR Report Key: 10642831
• MDR Text Key: 210633632
• Report Number: MW5097133
• Device Sequence Number: 1
• Product Code: KCO
• 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: 10/06/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 61