MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-15 for REWALK REHABILITATION manufactured by Argo Medical Technologies.
[3568442]
Patient was performing a sit-to-stand when the device malfunctioned. During the stand the knees extended, but the hips stayed relatively flexed. It seemed that the left hip stayed at 90 degrees while the right was trying to extend. The result was a bit of a twisting force combined with the hip flexion. The device stayed powered on during the entire sit-to-stand and was turned off by the therapist to help get the patient out of the device.
Patient Sequence No: 1, Text Type: D, B5
[10806306]
Evaluation is currently underway with no conclusions reached at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007615665-2013-00001 |
| MDR Report Key | 3113837 |
| Report Source | 05 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-05-11 |
| Date of Event | 2013-04-10 |
| Date Mfgr Received | 2013-04-21 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-05-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 33 LOCKE DR SUITE 204 |
| Manufacturer City | MARLBORO MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082511154 |
| Manufacturer G1 | ARGO MEDICAL TECHNOLOGIES, LTD. |
| Manufacturer Street | KOCHAV YOKNEAM BUILDING, FLOOR 6 P.O. BOX 161 |
| Manufacturer City | YOKNEAM ILLIT 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REWALK |
| Generic Name | 890.5380 |
| Product Code | BXB |
| Date Received | 2013-05-15 |
| Returned To Mfg | 2013-04-24 |
| Model Number | REHABILITATION |
| Catalog Number | REHABILITATION |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGO MEDICAL TECHNOLOGIES |
| Manufacturer Address | MARLBORO MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-05-15 |