FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3071311
·
Received April 22, 2013
Report
- Report Number
- 1054871-2013-00019
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 3, 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 CONTACTED NEPHRON PHARMACEUTICALS CORP REGARDING A PRODUCT COMPLAINT ON (B)(4) 2013. THE PT REPORTED THAT A WASHER FELL INTO HIS MOUTH WHILE USING THE EZ BREATHE ATOMIZER. THE CUSTOMER ADDED THAT HE NEARLY SWALLOWED THE WASHER, BUT HE WAS ABLE TO COUGH UP AND REMOVE THE COMPONENT FROM HIS MOUTH. THE PT 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 |
|---|---|---|---|---|---|---|---|
| 170965 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | UNIDENTIFIED |