FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3449901
·
Received October 29, 2013
Report
- Report Number
- 1054871-2013-00087
- Event Type
- Malfunction
- Date Received
- October 29, 2013
- Date of Event
- October 1, 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 OCTOBER 1, 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. HE ADDED THAT HE CLEANED THE ATOMIZER ACCORDING TO THE PRODUCT'S INSTRUCTIONS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE CUSTOMER VIA TELEPHONE UNSUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553710 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO. LTD. | EZ-100 | 121101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |