MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-12-12 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Ltd.
[130049061]
The cause for the user fall was loss of balance; however, it is not clear how the user lost her balance. With the available data it can be concluded that: the system was inspected and no malfunction was found. The user tried to walk alone - which is against our recommendations that every rewalk user, no matter how skilled, should have a trained rewalk companion assist him during use. The cause for the fall was the user's momentary loss of balance, probably while turning around to climb the stairs. A fitting adjustment was done about 20 min before the fall and was approved by the user - according to the ww training manager this fitting could make an impact on balance but is unlikely to cause the fall.
Patient Sequence No: 1, Text Type: N, H10
[130049062]
During walking with the rewalk device the patient lost balance and fell backwards; the patient (she) hit the ground with the back of her head. The health situation was unclear and she was taken to the hospital. The immediate outcome after the fall was: brachial plexus stretch left and right; brachial plexus compression left due to a hematoma; headache' the user was hospitalized and released after few days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007615665-2018-00017 |
| MDR Report Key | 8155073 |
| Report Source | FOREIGN |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-09-27 |
| Date Facility Aware | 2018-09-12 |
| Report Date | 2018-09-28 |
| Date Reported to Mfgr | 2018-09-28 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2018-12-12 |
| 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 | 2018-12-12 |
| Returned To Mfg | 2018-10-01 |
| Model Number | PERSONAL |
| Catalog Number | 50-20-0004 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 3 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 2069203, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-12 |