FDA Adverse Event
Other
Summary report: N
CONMED (ONE COMPONENT OF CUSTOM PACK)
MDR report key: 1040911
·
Received April 16, 2008
Report
- Report Number
- MW5006827
- Event Type
- Other
- Date Received
- April 16, 2008
- Date of Event
- April 15, 2008
- Report Date
- April 16, 2008
- Manufacturer
- CONMED-BOVIE/CARDINAL HEALTH (CUSTOM PACK)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BOVIE PENCIL STARTED SMOKING AFTER IT WAS USED ON PT. WAS NOT SMOKING DURING USE. PENCIL TAKEN OFF OF FIELD AND REPLACED WITH NEW PENCIL. CONMED PENCIL WAS PART OF CARDINAL HEALTH ACDF CUSTOM PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED (ONE COMPONENT OF CUSTOM PACK) | ROCKERSWITCH CAUTERY PENCIL | GEI | CONMED-BOVIE/CARDINAL HEALTH (CUSTOM PACK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |