FDA Adverse Event
Injury
Summary report: N
SARA 3000
MDR report key: 3832909
·
Received May 15, 2014
Report
- Report Number
- 3007420694-2014-00058
- Event Type
- Injury
- Date Received
- May 15, 2014
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. ZO.O.
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
REF IMP # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289751 | SARA 3000 | NONE | FSA | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |