MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-20 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Ltd.
[130979149]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007615665-2018-00018 |
| MDR Report Key | 8183930 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-11-14 |
| Date Facility Aware | 2018-09-12 |
| Report Date | 2018-11-14 |
| Date Reported to Mfgr | 2018-11-14 |
| Date Mfgr Received | 2018-11-16 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ISHAY TAL |
| Manufacturer Street | 3 HATNUFA ST. |
| Manufacturer City | YOKNEAAM, 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal | 2069203 |
| Manufacturer G1 | REWALK ROBOTICS LTD |
| Manufacturer Street | 3 HATNUFA ST. (6TH FLOOR) |
| Manufacturer City | YOKNE'AM 2069203, ISRAEL |
| Manufacturer Country | IS |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REWALK PERSONAL |
| Generic Name | POWERED EXSOSKELETON, PRODUCT CODE: PHL |
| Product Code | PHL |
| Date Received | 2018-12-20 |
| Returned To Mfg | 2018-11-22 |
| Model Number | PERSONAL |
| Catalog Number | 50-20-0004 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| 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 2069203, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-20 |