FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 2969492
·
Received February 19, 2013
Report
- Report Number
- 1054871-2013-00003
- Event Type
- Malfunction
- Date Received
- February 19, 2013
- Date of Event
- January 28, 2013
- Report Date
- February 11, 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 THE WASHER FELL INTO HIS MOUTH WHILE HE WAS INHALING A SOLUTION VIA THE EZ BREATHE ATOMIZER. HE WAS USING THE EZ BREATHE ATOMIZER TO HELP RELIEVE THE SYMPTOMS OF A COLD AND RECOVERED THE WASHER FROM HIS MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71099 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |