MAUDE Adverse Event Report: INHALER

Lot Number V425

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2018

Event Type  Injury  

Event Description

Hard to dispense correctly due to spray shooting into tongue lessening dosage, causing dry mouth and lips.Attached cover gets in the way when dispensing.Also design makes it difficult to fit in a woman's purse.My "proair" was perfect.

• Brand Name: INHALER
• Type of Device: INHALER
• MDR Report Key: 7337571
• MDR Text Key: 102500001
• Report Number: MW5075866
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Lot Number: V425
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 45