EZSTIM II ES400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-16 for EZSTIM II ES400 manufactured by Life-tech, Inc..

Event Text Entries

[2144330] After surgery, a burn on the patient's left temporal area was noted, where the nerve stimulator patch had been in place.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5020628
• MDR Report Key: 2097521
• Date Received: 2011-05-16
• Date of Report: 2011-05-16
• Date of Event: 2011-03-29
• Date Added to Maude: 2011-05-24
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: EZSTIM II
• Generic Name: PERIPHERAL NERVE LOCATOR AND STIMULATOR
• Product Code: KOI
• Date Received: 2011-05-16
• Model Number: ES400
• Lot Number: ES400
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIFE-TECH, INC.
• Manufacturer Address: 4235 GREENBRIAR DR STAFFORD TX 77477 US 77477

Device Sequence Number: 2

• Brand Name: REPOSITIONABLE MONITORING ELECTRODE
• Generic Name: PERIPHERAL NERVE LOCATOR AND STIMULATOR
• Product Code: KOI
• Date Received: 2011-05-16
• Model Number: ES400
• Lot Number: 2013-03 EF
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: LIFE-TECH, INC.
• Manufacturer Address: 4235 GREENBRIAR DR STAFFORD TX 77477 US 77477

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-05-16