FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3037332
·
Received March 18, 2013
Report
- Report Number
- 1054871-2013-00011
- Event Type
- Malfunction
- Date Received
- March 18, 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
- 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 SHE EXPERIENCED TWO PROBLEMS WITH TWO ATOMIZERS THAT SHE PURCHASED THE MEDICATION CUP LATCH WOULD NOT REMAIN CLOSED, AND THE ATOMIZERS WOULD NOT PRODUCE AS AEROSOL TO DELIVER THE MEDICATION. SEVERAL ATTEMPTS VIA EMAIL 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 |
|---|---|---|---|---|---|---|---|
| 113100 | 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. |