FDA Adverse Event
Injury
Summary report: N
REWALK PERSONAL
MDR report key: 7443790
·
Received April 19, 2018
Report
- Report Number
- 3007615665-2018-00008
- Event Type
- Injury
- Date Received
- April 19, 2018
- Date of Event
- October 14, 2016
- Report Date
- April 8, 2018
- Manufacturer
- REWALK ROBOTICS LTD.
- Product Code
- PHL
- PMA / PMN Number
- K160987
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION PROVIDED HEREIN WAS DISCLOSED TO THE FDA ON 3 OCCASIONS IN A ROOT CAUSE ANALYSIS (RDD0030) WHICH WAS PART OF; ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00003) DATED AUG 10, 2017. ADDITIONAL INFORMATION RESPONSE (MDR # 3007615665-2017-00004) DATED AUG 23, 2017. CLASS 2 DEVICE RECALL REWALK PERSONAL 6.0 (RECALL NUMBER Z-0944-2018, (B)(4)).
Description of Event or Problem · 1
THE USER REPORTED HIS LEFT KNEE WAS SWOLLEN DAYS AFTER A REWALK TRAINING SESSION. ACCORDING TO THE PTS NOTHING EXTRAORDINARY HAPPENED DURING THE SESSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288589 | REWALK PERSONAL | POWERED EXOSKELETON | PHL | REWALK ROBOTICS LTD. | PERSONAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Congenital Anomaly| R |