MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for REWALK P5 manufactured by Rewalk Robotics.
[99237711]
While patient was using rewalk for gait training, the pelvic band cracked and disengaged from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075078 |
| MDR Report Key | 7244557 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-26 |
| Date Added to Maude | 2018-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REWALK P5 |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2018-02-05 |
| Model Number | P5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REWALK ROBOTICS |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-05 |