MAUDE Adverse Event Report: NEOTECH PRODUCTS NEOTECH; NEOLEAD ECG ELECTRODS

Model Number N305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/11/2017

Event Type  Injury  

Manufacturer Narrative

Two returned leads and two sealed leads from the other complaint by the same hospital were sent to toxikon lab for evaluation due to previous incidents.The results showed normal hospital flora to be found on the used parts.Unopened retained samples of products were also sent to the same lab for testing and no bacteria was found on that sampling.A copy of test results is attached.Our senior clinical specialist has been in contact with the hospital to go over product dfu and also investigate if there were any outside factors that might have caused said events.During those conversations we were not able to determine any factors.Supplier stated that less than (b)(4) of general population might be acrylic sensitive and neonates might be more susceptible because of their undeveloped immune system.Certificate of conformance from supplier was also reviewed and attached to this report.This line of product has a biocompatibility test and result already ((b)(4)) on file.Per complaint ratio calculation the incident seem to be very rare to happen and we did not have any complaint similar to this from any other facility.This complaint will be monitored for trending purposes and is added to the related logs and charts.

Event Description

Neolead ecg electrode allegedly caused raised, weepy rash.

• Brand Name: NEOTECH
• Type of Device: NEOLEAD ECG ELECTRODS
• Manufacturer (Section D): NEOTECH PRODUCTS; 28430 witherspoon parkway; 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: 6401461
• MDR Text Key: 69839980
• Report Number: 2025917-2017-00102
• 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: Inspection
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: N305
• Device Catalogue Number: N305
• Device Lot Number: 2016-9003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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: 3 MO
• Patient Weight: 4