MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-16 for NUSTEP T5/T5 XR T5XR manufactured by Nustep, Inc..
[1460972]
While using the nustep equipment during a physical therapy rehabilitation session, the left 'arm' of the equipment came loose, swung downward, and struck the pt in the left knee. The pt did not sustain any acute trauma or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014795 |
| MDR Report Key | 1610356 |
| Date Received | 2010-02-16 |
| Date of Report | 2010-02-16 |
| Date of Event | 2010-01-26 |
| Date Added to Maude | 2010-03-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUSTEP T5/T5 XR |
| Generic Name | NUSTEP T5/T5 XR RECUMBENT CROSS TRAINER |
| Product Code | BXB |
| Date Received | 2010-02-16 |
| Model Number | T5XR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUSTEP, INC. |
| Manufacturer Address | 5111 VENTURE DRIVE SUITE 1 ANN ARBOR MI 48108 US 48108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-02-16 |