MAUDE Adverse Event Report: HEALTH & LIFE (SUZHOU) CO., LTD. EZ BREATH ATOMIZER

Model Number EZ-100

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Slipped (1584)

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

Event Type  No Answer Provided  

Event Description

The patient contacted (b)(4) corporation regarding a product complaint of loose washer on (b)(6) 2013, associated with the use of the ez breathe atomizer.The patient reported that a silver circular ring fell from the medication cup into his mouth while using the product.Multiple unsuccessful attempts were made to reach the customer via telephone; however, additional follow-up attempts will be conducted.In addition, an investigation notification letter will be mailed to the patient via (b)(4) that requires confirmation of the delivery.Medical review: an adverse event was not reported in association with this product complaint.

Manufacturer Narrative

An evaluation of this failure mode from the design failure modes and effects analysis of this product, that the use of the product in a manner likely to cause adverse health consequence is improbable.The root cause of this complaint cannot be identified, since the device was not returned yet.The complete investigation results will be included in the closure report, which will be submitted by (b)(4) 2014.

• Brand Name: EZ BREATH ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer (Section G): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9f, no 186 jian yi road, zhung he dist.; new taipei city 23553 ; 282271300
• MDR Report Key: 3594745
• MDR Text Key: 4065992
• Report Number: 3005442893-2013-00099
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/05/2013

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: Lay User/Patient
• Device Model Number: EZ-100
• Device Lot Number: 120801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other