FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3214865
·
Received July 9, 2013
Report
- Report Number
- 1054871-2013-00048
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 5, 2013
- Report Date
- July 2, 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 A WASHER FELL FROM THE EZ BREATHE ATOMIZER INTO HIS MOUTH WHILE USING THE DEVICE. HE REPORTED THAT HE DID NOT REQUIRE ANY MEDICAL INTERVENTIONS TO RECOVER THE COMPONENT. THE PT IS A (B)(6) MALE WITH A PAST MEDICAL HISTORY THAT IS SIGNIFICANT FOR ASTHMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311994 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO LTD | EZ-100 | 120901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other | REPORTED DURING THE INVESTIGATION.| THERE WERE NO CONCOMITANT MEDICAL PRODUCTS |