MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for EMG NEEDLE ELECTRODE 126-412-36TP manufactured by Chalgren Enterprises, Inc..
[23624991]
Patient Sequence No: 1, Text Type: N, H10
[23624992]
An electrode placed into thoracic spine. Running baseline data electrode smoke melted at cord causing raytec to catch fire. No fire on drape. Raytec to floor and saline placed on floor putting fire out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5018920 |
| MDR Report Key | 5018920 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-04-28 |
| Date of Event | 2015-04-27 |
| Report Date | 2015-04-28 |
| Date Reported to FDA | 2015-04-28 |
| Date Reported to Mfgr | 2015-04-28 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMG NEEDLE ELECTRODE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2015-08-20 |
| Model Number | 126-412-36TP |
| Lot Number | Y259 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHALGREN ENTERPRISES, INC. |
| Manufacturer Address | 380 TOMKINS COURT GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |