FDA Adverse Event
Injury
Summary report: N
SARA PLUS
MDR report key: 3081458
·
Received April 4, 2013
Report
- Report Number
- 3007420694-2013-00014
- Event Type
- Injury
- Date Received
- April 4, 2013
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. Z O.O.
- Product Code
- FNG
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139691 | SARA PLUS | ACTIVE FLOOR LIFTS | FNG | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |