MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-30 for REWALK REHABILITATION 50-30-0001 manufactured by Rewalk Robotics Ltd..
[5680684]
(b)(6) (pt at (b)(6)) reported that mw-2014-01 emailed (b)(6) on (b)(6) 2014 that she suffered a fracture of her tibia and fibula just above the right ankle. Mw-2014-01 says the fracture occurred during her rewalk session on (b)(6) 2014. (b)(6) feels the fracture may have occurred after adjustments were made to shorten the length of both the upper and lower segments on the device causing the knees to flex when coming from a sit to stand. A sit to stand was performed twice before the lower segments were lengthened. Mw-2014-01 said she noticed her right ankle area was not looking right the evening of (b)(6) 2014. On the morning of (b)(6) 2014 mw-2014-01 said the right ankle area still did not appear right and went to the er and was diagnosed with a fracture and placed in a cast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007615665-2014-00001 |
| MDR Report Key | 4645875 |
| Report Source | 05,07 |
| Date Received | 2015-03-30 |
| Date of Report | 2014-01-12 |
| Date of Event | 2013-12-09 |
| Date Mfgr Received | 2014-12-13 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN HAMILTON |
| Manufacturer Street | 33 LOCKE DRIVE |
| Manufacturer City | MARLBORO MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082511154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REWALK |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2015-03-30 |
| Model Number | REHABILITATION |
| Catalog Number | 50-30-0001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REWALK ROBOTICS LTD. |
| Manufacturer Address | MARLBORO MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-30 |