MAUDE Adverse Event Report: NEOTECH NEOTECH; NEOLEAD ECG ELECTRODS

Model Number N301

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Lead(s), Burn(s) From (3161)

Event Type  Injury  

Manufacturer Narrative

Device was not returned and no evaluation is possible on the actual device.However inspection records of two lots of products received from supplier on date 06/04/2015 (b)(4) and date 09/21/2015 (b)(4) during past 12 months were reviewed and no nonconformity was observed.Also certificates of conformance from supplier were reviewed.This line of product is biocompatible ((b)(4)).It seems to be a possibility that clinicians have not paid full attention to the dfu for closely monitoring patient to prevent elevation of problem.This complaint will be monitored for trending purposes and is added to the related logs and charts.

Event Description

Neolead ecg electrod allegdley caused blistring on 3 patients.No device number,lot number, patient information was provided by the center.

• Brand Name: NEOTECH
• Type of Device: NEOLEAD ECG ELECTRODS
• Manufacturer (Section D): NEOTECH; 28430 witherspoon parkway; valencia 91355
• Manufacturer (Section G): NEOTECH PRODUCTS, INC.; 28430 witherspoon pkw; valencia 91355
• Manufacturer Contact: leo arya ; 28430 witherspoon pkw; valencia 91355 ; 9135591355
• MDR Report Key: 6147711
• MDR Text Key: 61538251
• Report Number: 2025917-2016-00111
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N301
• Device Catalogue Number: N301
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other