MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-12 for ELECTROSURGICAL GENERATOR AND PENCIL SSE4, E2515H manufactured by Valleylab, Inc..
[15254191]
Pt was in surgery for bilateral blepharoplasty, under local anesthesia with nasal o2. Physician had completed the right eye and was completing the left eye using the electrosurgical machine with a pencil. Physician was using pencil on orbital fat when a loud noise was heard and a flame was noted to pt's lower face (nares chin area). Physician extinguished the fire with his hands and water was poured on pt's face. Pt was examined by plastic surgeon and burned area evaluated as 1st and 2nd degree burns. Physician ordered ice packs and cortisporin ointment to area from nares to chin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003661 |
| MDR Report Key | 16778 |
| Date Received | 1994-10-12 |
| Date of Report | 1994-09-27 |
| Date of Event | 1994-09-23 |
| Date Added to Maude | 1994-10-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROSURGICAL GENERATOR AND PENCIL |
| Generic Name | GENERATOR/HAND SWITCHING PENCIL |
| Product Code | HAM |
| Date Received | 1994-10-12 |
| Model Number | SSE4, E2515H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16711 |
| Manufacturer | VALLEYLAB, INC. |
| Manufacturer Address | BOULDER CO 80301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-12 |