FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3125214
·
Received May 6, 2013
Report
- Report Number
- 1054871-2013-00022
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 30, 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 PT REPORTED THAT A SILVER CIRCULAR PIECE FROM THE EZ BREATHE ATOMIZER FELL FROM THE DEVICE INTO HIS MOUTH WHILE IN USE. THE PT REPORTED THAT HE DID NOT SUFFER MEDICAL HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198146 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other | THIS INFORMATION WAS NOT IDENTIFIED DURING| THE INVESTIGATION. |