MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-10 for ELECTRODE manufactured by Somatics, Inc..
[18953123]
Pt sustained superficial burn from left temporal electrode during shock treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28998 |
| MDR Report Key | 28998 |
| Date Received | 1995-07-10 |
| Date of Report | 1995-07-01 |
| Report Date | 1995-07-01 |
| Date Added to Maude | 1995-12-27 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRODE |
| Generic Name | ELECTRODE |
| Product Code | BWK |
| Date Received | 1995-07-10 |
| Lot Number | SOM1702-093-ECI |
| Operator | OTHER |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29997 |
| Manufacturer | SOMATICS, INC. |
| Manufacturer Address | 910 SHERWOOD DR UNIT 17 LAKE BLUFF IL 60044 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-10 |