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 pt contacted neophron 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 pt reported that a silver ring fell from the device into his mouth while he was inhaling mist from the solution in the device.He added that he almost choked on the loose component.During a follow-up phone call on (b)(6) 2014, the pt reported that he sucked on the mouthpiece of the device, because the device did not produce a sufficient amount of mist to provide him with relief.He also added that the washer fell through the mouthpiece into his mouth; however, he was able to remove the washer without requiring any medical interventions.The pt is a (b)(6) year old male.The indication for use of the device and the pt's past medical history are unk.

Manufacturer Narrative

Company comment: this case report is serious based on the potential choking hazard.Causality is assessed as related.

• 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 & IFE CO., LTD; no. 1428 xiang jiang rd; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: 9f, no. 186 jian yi rd, zhung he dist.; new taipei city 23553 ; 282271300
• MDR Report Key: 3770859
• MDR Text Key: 4441774
• Report Number: 1054871-2014-00005
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/07/2014

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2014
• Distributor Facility Aware Date: 02/07/2014
• Date Report to Manufacturer: 03/07/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THIS INFORMATION IS UNK AT THIS TIME.
• Patient Outcome(s): Other
• Patient Age: 41 YR