FDA Adverse Event
Injury
Summary report: N
REWALK PERSONAL
MDR report key: 8183930
·
Received December 20, 2018
Report
- Report Number
- 3007615665-2018-00018
- Event Type
- Injury
- Date Received
- December 20, 2018
- Date of Event
- November 14, 2018
- Report Date
- December 20, 2018
- Manufacturer
- REWALK ROBOTICS LTD
- Product Code
- PHL
- PMA / PMN Number
- K160987
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
AFTER TRAINING ON THE REWALK DEVICE THE USER NOTICED THAT HER LEFT KNEE WAS SWOLLEN, AN X-RAY IMAGING TEST IDENTIFIED A TIBIAL PLATEAU FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1023099 | REWALK PERSONAL | POWERED EXSOSKELETON, PRODUCT CODE: PHL | PHL | REWALK ROBOTICS LTD | PERSONAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |