D
Patient 1
PATIENT BURNED ON LIP DURING PROCEDURE INVOLVING USE OF SUCTION CAUTERY PENCIL. BURN TREATED WITH ANTIBIOTIC SALVE, NO FURTHER TREATMENT NEEDED.
MAUDE MDR 319447
- MDR report key
- 319447
- Report number
- 1042100-2001-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-08-27
- Date received
- 2001-03-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NINA ALLEN
- Address
- 1317 FOURTH AVE AUBURN GA 30011 US
- Phone
- 770-770-7709
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STERI SYSTEM SUCTION CAUTERY PENCIL | ELECTROSURGICAL PENCIL | DURDEN ENTERPRISES | GEI | NA | 103-8425 | 583 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-03-06 | 0 | 1. O |