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

Model Number EZ-100

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems High Blood Pressure/ Hypertension (1908); Irritation (1941); Numbness (2415); Electric Shock (2554); No Code Available (3191)

Event Date 11/20/2013

Event Type  No Answer Provided  

Event Description

The patient contacted nephron pharmaceuticals corporation regarding a product complaint of electrical shock on (b)(6), 2013, associated with the ez breathe atomizer.The patient reported that he experienced an electrical shock in his truck after pressing the "on" button on the atomizer.In addition, he experienced numbness in his hands, tongue irritation and impaired speech.His right eyelid also drooped.The patient stated that the effects of the shock lasted for an hour, and he called the paramedics for medical assistance.During a follow-up phone call on (b)(6) 2013, the patient reported that he turned on the atomizer while the device was in his mouth when he was shocked.He added that he experienced voice alterations.Upon their arrival, the paramedics assessed that his blood pressure was 180/110 mmgh as opposed to his normal blood pressure of 138/78-90 mmgh.Paramedics assessed and released that patient.The patient is a (b)(6) male who is (b)(6).His past medical history is significant for bronchial asthma.

Manufacturer Narrative

The root cause of this event cannot be identified, since there's no evidence to prove that this "electric shock" is likely generated from the subject device.

• Brand Name: EZ BREATH 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 (Section G): HEALTH & LIFE (SUZHOU) CO., LTD.; no. 1428 xiang jiang road; suzhou new district; suzhou, jiang su 2151 29; CH 215129
• Manufacturer Contact: no. 186 jian yi road 9f; zhung he district; new taipei city 23553 ; 282271300
• MDR Report Key: 3817719
• MDR Text Key: 4394435
• Report Number: 3005442893-2013-00103
• 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: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• 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: 121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BENAZEPRIL (1 TABLET PO QD); CARVEDILOL (1 TABLET PO QD); UNIDENTIFIED MEDICATION (1 TABLET PO QD)
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 100