D
Patient 1
PT RECEIVED MINOR BURN DURING AN ENT SURGICAL PROCEDURE.
MAUDE MDR 468914
- MDR report key
- 468914
- Report number
- 1042100-2003-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-04-09
- Date received
- 2003-05-22
- 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#
- Address
- P.O. BOX 909 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, INC. | GEI | * | 103-4575 | 823 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-05-22 | 0 | 1. O |