FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3071314
·
Received April 22, 2013
Report
- Report Number
- 1054871-2013-00015
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- March 19, 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 COMPLAINANT REPORTED THAT A WASHER FELL INTO HIS MOUTH FROM THE EZ BREATHE ATOMIZER. HE REMOVED THE WASHER FROM HIS MOUTH. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER VIA TELEPHONE AND EMAIL. ALTHOUGH THE CUSTOMER INITIALLY WITHHELD INFO, HE STATED THAT HE WOULD INCLUDE THE SERIAL NUMBER OF THE PRODUCT WHEN IT IS RETURNED TO THE MFR. AT THIS TIME, NPC HAS NOT RECEIVED INFO FROM THE PT CONCERNING THE SERIAL NUMBER OF THE INVESTIGATED PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172010 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH & LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | UNIDENTIFIED |