MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Ltd..
| Report Number | 3007615665-2016-00004 |
| MDR Report Key | 6158926 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-10-26 |
| Date Facility Aware | 2016-11-21 |
| Report Date | 2016-11-21 |
| Date Reported to Mfgr | 2016-11-21 |
| Date Mfgr Received | 2016-11-21 |
| Device Manufacturer Date | 2015-12-18 |
| Date Added to Maude | 2016-12-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ARI SOBEL |
| Manufacturer Street | 200 DONALD LYNCH BOULEVARD |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082817271 |
| Manufacturer G1 | REWALK ROBOTICS LTD. |
| Manufacturer Street | 3 HATNUFA ST. (6TH FLOOR) |
| Manufacturer City | YOKNE'AM, ISRAEL 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REWALK PERSONAL |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2016-12-09 |
| Model Number | PERSONAL |
| Catalog Number | 50-20-0004 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REWALK ROBOTICS LTD. |
| Manufacturer Address | 3 HATNUFA ST. (6TH FLOOR) YOKNE'AM, ISRAEL 2069203 IS 2069203 |