FDA Adverse Event
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3113329
·
Received April 12, 2013
Report
- Report Number
- 3005442893-2013-00011
- Date Received
- April 12, 2013
- Date of Event
- February 27, 2013
- Report Date
- March 12, 2013
- Manufacturer
- HEALTH & LIFE (SUZHOU) CO., LTD.
- Product Code
- CCQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HEREWITH THE INVESTIGATION PLAN, THE INVESTIGATION RESULTS AND RELEVANT F/U ACTIVITIES WILL BE INCLUDED IN 2013 F/U.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. THE CUSTOMER REPORTED THAT SHE EXPERIENCED TWO PROBLEMS WITH TWO ATOMIZERS THAT SHE PURCHASED - THE MEDICATION CUP LATCH WOULD NOT REMAIN CLOSED, AND THE ATOMIZERS WOULD NOT PRODUCE AN AEROSOL TO DELIVER THE MEDICATION. SEVERAL ATTEMPTS VIA E-MAIL WERE MADE TO CONTACT THE CUSTOMER; HOWEVER, THE CUSTOMER ADVISED THAT NPC DISCONTINUE ALL FURTHER COMMUNICATION WITH HER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157214 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | THIS INFO WAS NOT IDENTIFIED DURING THE| INVESTIGATION. |