FDA Adverse Event
Injury
Summary report: N
REWALK (EITHER PERSONAL OR REHABILITATION)
MDR report key: 6224006
·
Received January 4, 2017
Report
- Report Number
- 3007615665-2017-00002
- Event Type
- Injury
- Date Received
- January 4, 2017
- Date of Event
- November 29, 2016
- Report Date
- January 4, 2017
- Manufacturer
- REWALK ROBOTICS LTD.
- Product Code
- PHL
- PMA / PMN Number
- K131798
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT SUSTAINED CALCANEAL FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3881 | REWALK (EITHER PERSONAL OR REHABILITATION) | POWERED EXOSKELETON | PHL | REWALK ROBOTICS LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |