FDA Adverse Event
Malfunction
Summary report: N
EZ BREATH ATOMIZER
MDR report key: 3096833
·
Received May 6, 2013
Report
- Report Number
- 1054871-2013-00021
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 3, 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 PIECE FELL FROM THE EZ BREATH ATOMIZER INTO HER MOUTH WHILE IN USE. THE PT ADDED THAT SHE DID NOT SUFFER ANY MEDICAL HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197189 | EZ BREATH ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO, LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other | THIS INFORMATION WAS NOT IDENTIFIED DURING THE| INVESTIGATION. |