S3 · 02/2021 · Medtronic Hugo
| Company | Medtronic Hugo |
| Category | medical robotics |
| Type | injury |
| Date | 02/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 2438477-2021-00000 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DEVICE IS A ROLLATOR WHICH WAS DISTRIBUTED AT THE TIME OF MANUFACTURE BY AMG MEDICAL IN CANADA. WE HAVE NOT RECEIVED THE UNIT BACK FOR EVALUATION. THE UNIT WAS MANUFACTURED IN 2014. END-USER WAS GETTING OFF THE ROLLATOR TO SIT ON A CHAIR. SHE USED ONE SIDE OF THE ROLLATOR TO SUPP
| 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 |