FDA Adverse Event
Injury
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3449861
·
Received October 29, 2013
Report
- Report Number
- 1054871-2013-00086
- Event Type
- Injury
- Date Received
- October 29, 2013
- Date of Event
- September 29, 2013
- Report Date
- October 29, 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 ASSOCIATED WITH THE EZ BREATHE ATOMIZER ON (B)(6) 2013. THE PT REPORTED THAT HE EXPERIENCED AN ASTHMA ATTACK AFTER THE EX BREATHE ATOMIZER FAILED TO PRODUCE AN AEROSOL MIST TO ALLEVIATE HIS ASTHMA SYMPTOMS. THE PATIENT ADDED THAT HE CLEANED THE ATOMIZER ACCORDING TO THE PRODUCT'S INSTRUCTIONS. THE PATIENT IS A (B)(6) YEAR OLD MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA. THE PATIENT DID NOT REPORT ANY ALLERGIES TO MEDICATION AND ADDED THAT HE DOES NOT SMOKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553955 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD | EZ-100 | 121101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| O | ASTHMANEFRIN INHALATION SOLUTION, 2.25% |