FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3723891
·
Received February 25, 2014
Report
- Report Number
- 1054871-2014-00003
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Report Date
- February 25, 2014
- Manufacturer
- HEALTH AND 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
NEPHRON PHARMACEUTICALS CORP. RECEIVED AN EMAIL ON (B)(6) 2014, REGARDING A PRODUCT COMPLAINT OF NO AEROSOL PRODUCTION THAT WAS REPORTED AS ASSOCIATED WITH THE USE OF THE EZ BREATHE ATOMIZER. THE PATIENT REPORTED THAT SHE EXPERIENCED A SERIOUS ASTHMA ATTACK AFTER THE ATOMIZER MALFUNCTIONED. MULTIPLE ATTEMPTS WERE MADE TO REACH THE PATIENT VIA TELEPHONE UNSUCCESSFUL; HOWEVER, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115710 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH AND LIFE (SUZHOU) CO., LTD. | EZ-100 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THIS INFORMATION IS UNKNOWN AT THIS TIME. |