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 Date 05/30/2014

Event Type  malfunction  

Event Description

(b)(4) received a product complaint of a loose washer malfunction on (b)(4) 2014, that was reported as associated with the use of the ez breathe atomizer.The pt's spouse reported that the pt used the device to administer asthmanefrin (racepinephrine inhalation solution, 2.25%) to alleviate his asthma symptoms.During a follow-up call on (b)(6) 2014, the initial reporter stated that she was sleeping at the time of the malfunction; however, the pt later informed the reporter that he felt a foreign object in his mouth when she woke.The pt brushed his teeth and noticed that a small washer was in his mouth.He was able to retrieve the component without requiring any medical interventions.There were no reports of any occurrences of a similar nature associated with the pt's use of the device.The pt is a (b)(6) year old male who is (b)(6).His past medical history is significant for asthma.Additional info concerning the pt's past medical history, medication regimen, and allergies are unk.The reporter added that the suspected device was purchased in (b)(6) 2013.The investigated product for the enclosed medical device report is listed among the implicated lots for a nationwide recall initiated by the mfr health and life, co., ltd., on (b)(4) 2013.The class 1 recall (z-1371-2013, z-1272-2013, z-1373-2013) was initiated after (b)(4), the importer, became aware of an increasing number of complaints associated with the possibility of a quarter-inch washer becoming dislodged from the ez breathe atomizer.The impacted atomizer serial number ranges are: (b)(4).

• Brand Name: EZ BREATHE 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 Contact: 9f, no. 186 jian yi road; zhung he dist.; new taipei city 23553 ; 282271300
• MDR Report Key: 3931349
• MDR Text Key: 4538659
• Report Number: 1054871-2014-00014
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/20/2014

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: 06/20/2014
• Distributor Facility Aware Date: 05/30/2014
• Event Location: Home
• Date Report to Manufacturer: 06/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASTHMANEFRIN (RACEPINEPHRINE INHALATION SOLUTION,; 2.25%
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 91