FDA Adverse Event
Injury
Summary report: N
EZ BREATH ATOMIZER
MDR report key: 3135423
·
Received May 22, 2013
Report
- Report Number
- 1054871-2013-00031
- Event Type
- Injury
- Date Received
- May 22, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 16, 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 CORPORATION REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT THE EZ BREATHE ATOMIZER FAILED TO PRODUCE AN AEROSOL OF ASTHMANEFRIN INHALATION SOLUTION TO ALLEVIATE HIS ASTHMA SYMPTOMS; FURTHERMORE, THE PT ADDED THAT HE EXPERIENCED AN ASTHMA ATTACK AND WAS ADMITTED TO A HOSPITAL FOR TREATMENT AS A RESULT OF THE ATOMIZER FAILING TO FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226585 | EZ BREATH ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization| O | ASTHMANEFRIN INHALATION SOLUTION |