MAUDE Adverse Event Report: HEALTH AND 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 nephron pharmaceuticals corp 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 the plate a fell from the atomizer to the back of her tongue; however, the pt did not swallow the component.During a follow-up phone call on (b)(6) 2014, the pt's friend reported that she observed the event when the plate a fell into the pt's mouth; however, the reporter did not recall when the event occurred.The reporter stated that the pt retrieved the washer from her mouth while requiring any medical interventions.The pt is a (b)(6).Her past medical history is significant for chronic obstructive pulmonary disease.The pt currently smokes, and she continues to use the other ez breathe atomizers with no occurrences of a similar nature.

• Brand Name: EZ BREATHE ATOMIZER
• Type of Device: ATOMIZER
• Manufacturer (Section D): HEALTH AND LIFE (SUZHOU) CO., LTD; xiang jiang rd, no. 1428; 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: no 186 jian yi rd, 9f; zhung he dist; new taipei city 23553 ; 282271300
• MDR Report Key: 3674924
• MDR Text Key: 17611622
• Report Number: 1054871-2014-00002
• 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: 02/26/2014

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: 120801
• 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: 02/26/2014
• Distributor Facility Aware Date: 01/29/2014
• Event Location: Home
• Date Report to Manufacturer: 02/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 68