MAUDE Adverse Event Report: EZ BREATHE ATOMIZER - ASTHMA MANAGER; EZ BREATHE AUTOMIZER

Device Problems Detachment Of Device Component (1104); Nonstandard Device (1420); Defective Device (2588)

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

Event Type  malfunction  

Event Description

My ez breathe atomizer has a piece that keeps falling off and i need my asthma controlled.There has been a recall on the product and i would like mine replaced since i bought a defected product unbeknown and uninformed.This product is pretty pricey to have to replace it on my own due to a manufacturing mishap.I could have choked!.

• Brand Name: EZ BREATHE ATOMIZER - ASTHMA MANAGER
• Type of Device: EZ BREATHE AUTOMIZER
• MDR Report Key: 4300502
• MDR Text Key: 5269780
• Report Number: MW5039380
• Device Sequence Number: 1
• Product Code: CCQ
• 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: 12/01/2014

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 Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2014
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 73