MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-20 for TREADMILL SERIES 2100 manufactured by Critikon De Mexico S. De R.l. De C.v..
[80754603]
The initial reporter is located outside the u. S. And therefore this information is not provided due to country privacy laws. Ge investigation is ongoing at this time. A follow-up will submitted when the investigation is complete. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[80754604]
The customer alleges the treadmill 2100 went backwards and fast during patient use. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2017-00009 |
| MDR Report Key | 6729914 |
| Date Received | 2017-07-20 |
| Date of Report | 2018-04-13 |
| Date of Event | 2017-06-24 |
| Date Mfgr Received | 2018-03-27 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-07-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YOUSSEF HALAS |
| Manufacturer Street | 8200 W TOWER AVE. |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3005860720-04/10/18-002- |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TREADMILL SERIES 2100 |
| Generic Name | POWERED TREADMILL |
| Product Code | IOL |
| Date Received | 2017-07-20 |
| ID Number | UDI NOT APPLICABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-20 |