MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-25 for EZ BREATHE ATOMIZER EZ-100/ HL 100 manufactured by Health & Life (suzhou)co., Ltd..
[37623093]
The root cause of this event cannot be identified, since the unit still not returned to manufacturer for further analysis. However, the preliminary evaluate result is determined to be similar to the event of the mdr 3005442893-2012-00004. As for the known possible cause, health & life company have been taking preventative action and corrective action to eliminate the root cause and recurrence. Furthermore, for the complained devices, health & life has initiated voluntary recall,and the recall notification letter and required recall materials were issued and submitted on apr-24 and apr-30 2013, respectively. The recall action is still on the process.
Patient Sequence No: 1, Text Type: N, H10
[37623094]
Nephron pharmaceuticals corporation received a report of an adverse event and malfunction on (b)(6) 2015, that was associated with the use of the ez breathe atomizer. During the initial phone call to nephron, the patient reported that a piece of the mesh component separated from the device and went in his throat. The patient did not respond to the initial follow-up phone call on (b)(6) 2015; however, the patient did respond to a second follow-up phone call on (b)(6) 2015. During the second follow-up phone call, the patient reported that a mesh component fell from the device and cut his trachea; furthermore, the component is still in his trachea. The patient reported that the adverse event occurred during his second time using the device. He added that the event occurred after he left the hospital for a bleeding ulcer on (b)(6) 2014, and he lost 80% stamina and 30% of his breathing capacity as a result of the malfunction. According to the patient, the device "blew up" after he activated the unit. He laid on the couch for the remainder of the night and went by ambulance to the hospital on the following day. While at the hospital, the patient was treated for a bleeding ulcer and received a cat scan that showed scattered metal. He stated that the device component looked like metal. The patient terminated the call prematurely before he additional questions were asked. During a third follow-up phone call on (b)(6) 2015, the patient reported that he is consulting with his heart physician regarding the mesh component. Furthermore, he added that he has lost 70% of his breathing capacity and stamina. He added that he used the product to alleviate chest congestion that was potentially associated with chronic obstructive pulmonary disease. Upon further questioning, the patient terminated the call prematurely. The patient is a (b)(6) male who is a former smoker. He added that he used the product to alleviate chest congestion; moreover, the patient stated that he is starting to develop chronic obstructive pulmonary disease. As stated previously, the patient terminated multiple telephone calls prematurely. The patient also refused to provide additional information regarding his height, weight, past medical history and contact information. The device was not returned to nephron for the investigation; therefore, the malfunction is determined to be unconfirmed at this time. The patient of his hospitalization suggests that the event is serious; therefore, a mdr will be submitted for this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005442893-2015-00004 |
| MDR Report Key | 5388135 |
| Date Received | 2016-01-25 |
| Date of Report | 2015-12-22 |
| Date of Event | 2014-11-15 |
| Date Mfgr Received | 2015-12-25 |
| Date Added to Maude | 2016-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SARAH SU |
| Manufacturer Street | NO.1428 XIANG JIANG ROAD |
| Manufacturer City | SUZHOU, JIANG SU 215129 |
| Manufacturer Country | CH |
| Manufacturer Postal | 215129 |
| Manufacturer Phone | 5126690910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EZ BREATHE ATOMIZER |
| Generic Name | ATOMIZER |
| Product Code | CCQ |
| Date Received | 2016-01-25 |
| Model Number | EZ-100/ HL 100 |
| Lot Number | 130301 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTH & LIFE (SUZHOU)CO., LTD. |
| Manufacturer Address | NO.1428 XIANG JIANG ROAD SUZHOU CITY, JIANG SU 215129 CH 215129 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-01-25 |