FDA Adverse Event
Injury
Summary report: N
BOVIE MEDICAL CORPORATION
MDR report key: 3703779
·
Received March 5, 2014
Report
- Report Number
- 3007593903-2014-00001
- Event Type
- Injury
- Date Received
- March 5, 2014
- Date of Event
- January 14, 2014
- Report Date
- February 5, 2014
- Manufacturer
- BOVIE MEDICAL CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K000961
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE POWER SETTING ON THE UNIT IN THE AS REC'D CONDITION WAS AT 12 WATTS. THE DEVICE AND THE CUSTOMER PROVIDED GROUNDING PLATE (A802EU) AND POWER CORD WAS TESTED IN THE REC'D STATE PER BOVIE PROCEDURE QA-354. THE UNIT MET ALL TEST REQUIREMENTS WITH NO ISSUES OR ANOMALIES SEEN. THE CUSTOMER CONFIRMED THAT CONDUCTIVE GEL WAS NOT USED AND HAD NEVER BEEN USED.
Description of Event or Problem · 1
DURING A DENTAL PROCEDURE USING THE DESICCATOR (SAME SETUP) AND GROUNDING PLATE, TWO PTS REC'D BURNS (SECOND DEGREE) UNDER THE PLATE. THE GROUNDING PLATE WAS PLACED ON THE PT'S STOMACH W/O THE USE OF CONDUCTIVE GEL. NO INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134112 | BOVIE MEDICAL CORPORATION | ELECTROSURGICAL DESICCATOR | GEI | BOVIE MEDICAL CORPORATION | A940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | A802EU GROUNDING PLATE WITH CORD |