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

Model Number EZ-100

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104)

Patient Problem Choking (2464)

Event Type  malfunction  

Event Description

The patient contacted nephron pharmaceuticals corporation via telephone on (b)(6) 2014, regarding a product complaint of loose washer that was reported as associated with the malfunction of the ez breathe atomizer.The patient reported that a loose washer fell from the medication cup into her mouth while using the device.During a follow-up phone call on (b)(6) 2014, the patient reported that the malfunction occurred during the final quarter of 2013.She added that she recovered the atomizer component without requiring any medical intervention.The patient is a (b)(6) year old female with a past medical history that is significant for asthma.She is a former cigarette and marijuana smoker.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH & LIFE (SUZHOU) CO. LTD.; no. 1428 xiang jiang rd; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer (Section G): HEALTH & LIFE CO. LTD.; no. 1428 xiang jiang rd; 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: 3708611
• MDR Text Key: 18364665
• Report Number: 1054871-2014-00006
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 03/19/2014

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: Lay User/Patient
• Device Model Number: EZ-100
• Device Lot Number: 120901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Distributor Facility Aware Date: 02/24/2014
• Event Location: Home
• Date Report to Manufacturer: 03/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR