MAUDE Adverse Event Report: NEOTECH NEOTECH; NEOLEAD ECG ELECTRODS

Model Number N305

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/08/2016

Event Type  Injury  

Manufacturer Narrative

Actual device was not returned, but two other returned parts from the same lot number were sent to the lab to be cultured.The inspection records were reviewed and no relevant nonconformity was observed.Product has certificate of conformance.This line of product is biocompatible per (b)(4).This complaint will be monitored for trending purposes and is added to the related logs and charts.Actual device was not returned.

Event Description

Nurse reported burns from ekg leads, when removed.

• 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 parkway; valencia 91355 ; 6617757466
• MDR Report Key: 6094348
• MDR Text Key: 59717095
• Report Number: 2025917-2016-00106
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 02/01/2018
• Device Model Number: N305
• Device Catalogue Number: N305
• Device Lot Number: 2016-9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 MO
• Patient Weight: 3