MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-31 for T2100 TREADMILL 2024315-001 manufactured by Critikon De Mexico S. De R.l. De C.v..
| Report Number | 3008729547-2019-00010 |
| MDR Report Key | 9263159 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-31 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-10-03 |
| Date Mfgr Received | 2019-10-03 |
| Device Manufacturer Date | 2010-11-29 |
| Date Added to Maude | 2019-10-31 |
| 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 | KRISTOF SOOS |
| Manufacturer Street | 8200 W. TOWER AVE. |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T2100 TREADMILL |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2019-10-31 |
| Model Number | 2024315-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE DEL CEDRO 1551 JUAREZ 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-31 |