FDA Adverse Event
Other
Summary report: N
EZ BREATHE ATOMIZER
MDR report key: 3001239
·
Received March 12, 2013
Report
- Report Number
- 1054871-2013-00009
- Event Type
- Other
- Date Received
- March 12, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 6, 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 VIA TELEPHONE REGARDING A PRODUCT COMPLAINT ON (B)(6) 2013. SHE REPORTED THAT A SILVER PIECE FELL FROM THE EZ BREATHE ATOMIZER INTO HER MOUTH WHILE SHE WAS USING THE PRODUCT. THE CUSTOMER REPORTED THAT SHE RECOVERED THE COMPONENT AND DID NOT REQUIRE ANY MEDICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104219 | EZ BREATHE ATOMIZER | ATOMIZER | CCQ | HEALTH AND LIFE (SUZHOU) CO., LTD. | EZ-100 | UNIDENTIFIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other | ADVAIR INHALER| PROAIR INHALER| ALBUTEROL SULFATE INHALATION SOLUTION| SHE REPORTS THAT SHE HAS PRESCRIPTIONS FOR A |