MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-01-14 for TREADMILL-2100 manufactured by Critikon De Mexico S. De R.l. De C.v..
[21733614]
A ge field engineer was working on a treadmill motor and had the treadmill belt running while wiping off excess silicon. The rag being used to wipe off the excess silicon became caught in the moving belt and dragged the employee's left middle finger onto belt. The engineer required stitches.
Patient Sequence No: 1, Text Type: D, B5
[21915502]
Info not known. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2014-00001 |
| MDR Report Key | 3595408 |
| Report Source | 01,07 |
| Date Received | 2014-01-14 |
| Date of Report | 2013-11-28 |
| Date of Event | 2013-11-28 |
| Date Mfgr Received | 2013-11-28 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2014-01-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD W450 |
| Manufacturer City | WAUKESHA WI 531880000 |
| Manufacturer Postal | 531880000 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer City | JUAREZ |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREADMILL-2100 |
| Generic Name | TREADMILL, POWERED |
| Product Code | BXB |
| Date Received | 2014-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | JUAREZ MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-14 |