FDA Adverse Event
Injury
Summary report: N
SOFRADIM PRODUCT
MDR report key: 3394012
·
Received November 28, 2012
Report
- Report Number
- 9615742-2012-00602
- Event Type
- Injury
- Date Received
- November 28, 2012
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #414863 FOR AN "UNK SOFRADIM".
Description of Event or Problem · 1
PLEASE REFER IMPORTER REPORT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFRADIM PRODUCT | SOFRADIM PRODUCT | OTN | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |