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 Date 07/28/2015

Event Type  malfunction  

Event Description

Nephron pharmaceuticals corporation received a malfunction complaint of a loose washer on (b)(6) 2015, that was reported as associated with the use of the ez breathe atomizer.The patient reported that a washer became dislodged from the device and fell in his throat.During a follow-up phone call on (b)(6) 2015, the patient reported that a small washer separated from the medication cup and fell into his throat.He added that the device fell into his throat while he was inhaling asthmanefrin inhalation solution, 2.25% from the device; however, the patient was able to retrieve the loose washer.He stated that he was breathing the medication through the device's mouthpiece when the malfunction occurred; moreover, he was using the device to treat a mild asthma exacerbation.The patient has used the device intermittently for at least 1.5-2 years; however, he did not use the device for a few months before using the device on (b)(6) 2015.The patient is a (b)(6) year old male with a past medical history that is significant for asthma.He is a former smoker and reported that he experiences an upset stomach when he used feldence (piroxicam).

Manufacturer Narrative

During the follow-up phone call, the patient reported that a washer-like component fell from the device; furthermore, the patient was able to retrieve the washer without requiring any medical interventions, and he did not experience medical harm.He added that the washer ejected from the medication cup while he was inhaling the racepinephrine product from the mouthpiece; however, the patient's atomizer instructions indicate that the patient should only inhale the mist emitted into the air from the atomizer instead of inhaling from the mouthpiece.The patient reported that he will return the device to the manufacturer to assist in the investigation.The investigated product for the enclosed medical device report is listed among the implicated lots for a nationwide recall initiated by the manufacturer health and life, co., ltd., on may 8, 2013.The class 1 recall (z-1371-2013, z-1372-2013, z-1373-2013) was initiated after nephron pharmaceuticals corporation, 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 AND LIFE (SUZHOU) CO., LTD; no. 128 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: 4962985
• MDR Text Key: 20070856
• Report Number: 1054871-2015-00004
• 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: 07/31/2015

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: 07/31/2015
• Distributor Facility Aware Date: 07/29/2015
• Device Age: 35 MO
• Event Location: Home
• Date Report to Manufacturer: 07/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RACEPINEPHRINE INHALATION SOLUTION, 2.25%; ASTHMANEFRIN INHALATION SOLUTION, 2.25%
• Patient Age: 67 YR