MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for ELECTROSURGICAL EQUIPMENT (GENERATOR) SSE 4 (PENCIL) E 2515H manufactured by Valley Lab.
[15229]
Patient was in surgery for bilateral blephroplasty, under local anesthesia with nasal 02. 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 patient's lower face (nares to chin area). Physician extingushed the fire with his hands and water was poured on patient face. Pt. Was examined by plastic surgeon and burned area evaluated as 1st and 2nd degree burns. Physician orderal ice packs and cortisporin ointment to area from nares to chin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25788 |
| MDR Report Key | 25788 |
| Date Received | 1995-01-19 |
| Date of Report | 1994-09-27 |
| Date of Event | 1994-09-23 |
| Date Added to Maude | 1995-09-20 |
| 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 | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | ELECTROSURGICAL EQUIPMENT |
| Generic Name | GENERATOR/HANDSWITCHING PENCIL |
| Product Code | HAM |
| Date Received | 1995-01-19 |
| Model Number | (GENERATOR) SSE 4 |
| Catalog Number | (PENCIL) E 2515H |
| Lot Number | (PENCIL) 20159 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16711 |
| Manufacturer | VALLEY LAB |
| Manufacturer Address | P.O. BOX 100991 ATLANTA GA 30384 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-01-19 |