FDA Adverse Event
Summary report: N
FORCE FX P9H 1064EA
MDR report key: 3167686
·
Received March 18, 2008
Report
- Report Number
- 3167686
- Date Received
- March 18, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 19, 2008
- Manufacturer
- VALLEYLAB
- Product Code
- DRX
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NM, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE BOVIE PAD PLACED ON THE PATIENT. BOVIE PAD WAS PROPERLY FIT AND STUCK TO THE PATIENT SECURELY. DURING THE PROCEDURE THE BOVIE PAD INDICATOR REMINDED GREEN HOWEVER THE SURGEON DID NOT FEEL THE BOVIE PENCIL WAS WORKING AT FULL POWER 40/40. A NEW BOVIE PENCIL WAS WORKING BETTER, BOVIE PAD WAS NEVER CHANGED AND REMAINED INTACT. BOVIE SITE WAS INSPECTED POSTOP AND A 4CM BURN WAS NOTED ON RIGHT THIGH. DR NOTIFIED, 2X2 GAUZE AND BACITRACIN OINTMENT PLACED ON BURN. ALL BOVIE PADS WITH LOT NUMBER 134440 WERE WITHDRAWN FROM SUPPLY ROOM AND OPERATING ROOMS. BOVIE UNIT BEING EVALUATED BY TECHNICAL SERVICES DEPARTMENT AT PRESENT. UNSURE AT THIS TIME WHETHER PROBLEM RESULTED FROM GROUNDING PADS OR MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FORCE FX P9H 1064EA | BOVIE | DRX | VALLEYLAB | MODELE8006 | LOT 62661-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Required Intervention | BOVIE PAD: LOT NUMBER: 134440 |