FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3214863
·
Received July 9, 2013
Report
- Report Number
- 1054871-2013-00047
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 5, 2013
- Report Date
- July 2, 2013
- Manufacturer
- HEALTH & LIFE (SUZHOU) CO LTD
- Product Code
- CCQ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ON (B)(6)2013. THE CUSTOMER REPORTED THAT THE EZ BREATHE ATOMIZER DID NOT PRODUCE A MIST WHILE SHE WAS USING THE PRODUCT TO ALLEVIATE AN ASTHMA EXACERBATION. THE PT ADDED THAT HER HUSBAND TOOK HER TO THE URGENT CARE FACILITY TO ALLEVIATE HER ASTHMA SYMPTOMS. THE PT IS A (B)(6) FEMALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314193 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO LTD | EZ-100 | 120801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other | THERE WERE NO CONCOMITANT MEDICAL PRODUCTS| REPORTED DURING THE INVESTIGATION. |