MAUDE Adverse Event Report: NEOTECH NEOTECH; NEOLEAD ECG ELECTRODS

Model Number N315

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

Device was returned and sent to the lab to be cultured.Based on the hospital's report the direction of use was not followed.Instead of using water only, they used soap and water to remove leads.The inspection records were reviewed and no relevant nonconformity was observed.Product has certificate of conformance.This line of product is biocompatible per namsa ref # (b)(4).This complaint will be monitored for trending purposes and is added to the related logs and charts.

Event Description

Nurse bathing patient and used soap and water to remove leads.After bath, nurse noticed reddened areas on the patient's chest where leads were placed, right upper abrasion was weeping.

• 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 ; 6617757466
• MDR Report Key: 6094354
• MDR Text Key: 59715052
• Report Number: 2025917-2016-00017
• 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: 05/01/2018
• Device Model Number: N315
• Device Catalogue Number: N315
• Device Lot Number: 2016-9020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2016
• 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: 41 DA
• Patient Weight: 4