FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3012018
·
Received March 18, 2013
Report
- Report Number
- 1054871-2013-00010
- 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 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 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 |
|---|---|---|---|---|---|---|---|
| 112636 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | INVESTIGATION.| THIS INFORMATION WAS NOT IDENTIFIED DURING THE |