MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-28 for LOKOMATPRO LOKOMATPRO L6.2 AD 30000 manufactured by Hocoma Ag.
| Report Number | 3003781275-2020-00001 |
| MDR Report Key | 9639487 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-01-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | HOCOMA AG |
| Manufacturer Street | INDUSTRIESTRASSE 4B |
| Manufacturer City | VOLKETSWIL, 8604 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOKOMATPRO |
| Generic Name | ISOKINETIC TESTING AND EVALUATION SYSTEM |
| Product Code | IKK |
| Date Received | 2020-01-28 |
| Model Number | LOKOMATPRO L6.2 AD |
| Catalog Number | 30000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOCOMA AG |
| Manufacturer Address | INDUSTRIESTRASSE 4B VOLKETSWIL, 8604 SZ 8604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |