MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-11-05 for LOKOMAT-SYSTEM 4.0 NA manufactured by Hocoma Ag.
[343542]
A trained and certificate therapist was training a pt with a spinal cord injury on the lokomat. It was a recurrence training of the pt. After a few minutes of training the foot of the pt got gaught on the treadmill during the beginning of the swingphase. The tension of the lower leg caused by the treadmill made the tibia of the pt to break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003781275-2004-00001 |
| MDR Report Key | 553523 |
| Report Source | 08 |
| Date Received | 2004-11-05 |
| Date of Report | 2004-10-29 |
| Date of Event | 2004-10-11 |
| Date Mfgr Received | 2004-10-12 |
| Device Manufacturer Date | 2004-07-01 |
| Date Added to Maude | 2004-11-08 |
| 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 | 0 |
| Manufacturer Contact | KEVIN WALLS |
| Manufacturer Street | 13 RED FOX LANE |
| Manufacturer City | LITTETON CA 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | HOCOMA AG |
| Manufacturer Street | * |
| Manufacturer City | VOLKETSWIL CH-8604 |
| Manufacturer Country | * |
| Manufacturer Postal Code | CH-8604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LOKOMAT-SYSTEM |
| Generic Name | POWERED EXERCISE EQUIPMENT |
| Product Code | ISD |
| Date Received | 2004-11-05 |
| Model Number | 4.0 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 543130 |
| Manufacturer | HOCOMA AG |
| Manufacturer Address | * VOLKETSWIL * CH-8604 |
| Baseline Brand Name | LOKOMAT-SYSTEM |
| Baseline Generic Name | POWERED EXCERXIS EQUIPMENT |
| Baseline Model No | 4.0 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-11-05 |