FDA Adverse Event
Injury
Summary report: N
SODIUM CHLORIDE NEPHRON 7% 4ML
MDR report key: 9535673
·
Received December 30, 2019
Report
- Report Number
- MW5091942
- Event Type
- Injury
- Date Received
- December 30, 2019
- Date of Event
- December 24, 2019
- Report Date
- December 24, 2019
- Manufacturer
- NEPHRON PHARMACEUTICALS / NEPHRON SC, INC.
- Product Code
- CAF
- UDI-DI
- 00487900760
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WAS HOSPITALIZED AND IS ON ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1323542 | SODIUM CHLORIDE NEPHRON 7% 4ML | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | NEPHRON PHARMACEUTICALS / NEPHRON SC, INC. | 924231 | 00487900760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Hospitalization |