MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-02 for REWALK PERSONAL 50-20-0004 manufactured by Rewalk Robotics Marlborough, Ma.
[61396548]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[61396549]
Pt texted and called reporting swelling in his r knee after a session of walking 1100 steps. He saw his physician who did an x-ray which was negative for fracture and he was diagnosed with bursitis. Update 8/16/2016 patient called after urgent care called with the results of his x-ray. They identified a small compression fracture of his r medial plateau. The patient was told to speak with his physician regarding treatment. His physician was emailed the update/news by rewalk robotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007615665-2016-00001 |
| MDR Report Key | 6142528 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-02 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-08-14 |
| Date Mfgr Received | 2016-08-14 |
| Date Added to Maude | 2016-12-02 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REWALK PERSONAL |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2016-12-02 |
| Model Number | PERSONAL |
| Catalog Number | 50-20-0004 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REWALK ROBOTICS MARLBOROUGH, MA |
| Manufacturer Address | 200 DONALD LYNCH BOULEVARD MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-02 |