S3 · 03/2021 · Medtronic Hugo
| Company | Medtronic Hugo |
| Category | medical robotics |
| Type | injury |
| Date | 03/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2438477-2021-00009 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CANE. THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL FILE A FOLLOW-UP SUBMISSION WHEN MORE DATA BECOMES AVAILABLE. WE ARE FILING THIRD REPORT IN AN OVER-ABUNDANCE OF CAUTION. WHILE IN USE ONE OF T
| Sev | Date | Company | Event |
|---|---|---|---|
| S2 | 2015-06-30 | Hocoma | Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training |