FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3071295
·
Received April 22, 2013
Report
- Report Number
- 1054871-2013-00020
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 16, 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 ORIGINALLY CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ON (B)(4) 2013. IN THIS ABSENCE, THE PT'S WIFE REPORTED THAT A WASHER FELL INTO HER HUSBAND'S MOUTH WHILE USING THE EZ BREATH ATOMIZER. THE CUSTOMER ADDED THAT HE WAS ABLE TO SUCCESSFULLY REMOVE THE COMPONENT FROM HIS MOUTH. THE PT'S WIFE REPORTED THAT HE DID NOT EXPERIENCE ANY MEDICAL HARM OR REQUIRE ANY MEDICAL INTERVENTIONS FOLLOWING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171953 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | UNIDENTIFIED |