FORCE FX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-09-10 for FORCE FX manufactured by Valleylab.

Event Text Entries

[1148202] Pt was prepped with mini-chloraprep. During electrocautery excision of skin lesion on left cheek, surgical fire extinguished. Pt sustained second degree burns of the oropharynx and face. Apparent cause was free flow oxygen by nasal canula beneath drapes that was ignited by a bovie spark. Bovie machine was tested and found to be in working order. Dose, frequency & route used: once, topical 060. Therapy dates: 2009. Diagnosis for use: preoperative.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1474486
• MDR Report Key: 1474486
• Report Source: 99
• Date Received: 2009-09-10
• Date of Report: 2009-09-08
• Date of Event: 2009-08-26
• Date Facility Aware: 2009-08-26
• Report Date: 2009-09-08
• Date Reported to FDA: 2009-09-09
• Date Reported to Mfgr: 2009-09-09
• Date Added to Maude: 2009-09-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: FORCE FX
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: GEI
• Date Received: 2009-09-10
• Model Number: FORCE FX
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 6 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: VALLEYLAB
• Manufacturer Address: 5920 LONGBOW DRIVE BOULDER CO 80301329 US 80301 3299

Device Sequence Number: 2

• Brand Name: 2% W/V CHORHEXIDINE GLUCONATE
• Generic Name: NONE
• Product Code: KOY
• Date Received: 2009-09-10
• ID Number: 054365-400-12
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH

Device Sequence Number: 3

• Brand Name: AIRLIFE
• Generic Name: ADULT CUSHION NASAL CANNULA
• Product Code: CAT
• Date Received: 2009-09-10
• Catalog Number: 002600
• Lot Number: Y09J2011
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH, INC.
• Manufacturer Address: 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2009-09-10