FDA Adverse Event
Malfunction
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3113834
·
Received May 15, 2013
Report
- Report Number
- 1054871-2013-00029
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 9, 2013
- Manufacturer
- HEALTH AND 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 CUSTOMER REPORTED THAT THE WASHER FROM THE EZ BREATHE ATOMIZER FELL INTO HIS MOUTH WHILE HE WAS INHALING ASTHMANEFRIN INHALATION SOLUTION. THE CUSTOMER COUGHED THE COMPONENT BACK UP AND DID NOT SUFFER ANY MEDICAL HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215364 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH AND LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | THERE WERE NO CONCOMITANT MEDICAL PRODUCTS| REPORTED DURING THE INVESTIGATION. |