FDA Adverse Event
Other
Summary report: N
HAND CONTROLLED PENCIL
MDR report key: 2445480
·
Received February 7, 2012
Report
- Report Number
- MW5024166
- Event Type
- Other
- Date Received
- February 7, 2012
- Date of Event
- January 22, 2012
- Report Date
- January 31, 2012
- Manufacturer
- CONMED
- Product Code
- GEI
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CAUTERY PENCILS USED FROM LOT# 110815-5, X2 WITH SETTINGS AT USUAL 60 CUT/60 COAG, BURNED PHYSICIAN'S GLOVES WHEN USING SAME. THE FIRST CAUTERY PENCIL USED (SAVED POST-OP AND NUMBERED 1) BURNED A HOLE IN DOCTOR'S TOP GLOVE. THE REPLACEMENT CAUTERY PENCIL (SAVED AND NUMBERED 2) ACTUALLY CAUSED A 'FLAME' (SEEN BY DOCTOR) AND BURNED THROUGH HIS TOP AND BOTTOM GLOVES WORN (RIGHT LONGEST/MID FINGER).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAND CONTROLLED PENCIL | GEI | CONMED | 110815-5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |