MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOTECH PRODUCTS; NEOLEAD

Model Number	N301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Chest excoriation and redness.
Additional Manufacturer Narrative
We received 3 letters (mw5111256, mw5111257, mw5111259) from fda that one hospital reported 3 skin reactions while using ecg electrodes.In two of the reports the mentioned lot number did not exist.We have conducted skin irritation/sensitization testing for both hydrogel and hydrocolloid sections of the ekg electrode in accordance with the guidelines of the international organization for standardization 10993 part 10.The results were categorized as negligible.Based on the clinical information provided and the supplier test results we were not able to determine a definitive cause for the reported incidence.Possible causes that could not be ruled out include malfunction of the monitoring device, acrylic skin sensitivity, and/or hyper-reactivity of the infant's immature skin/immune system.Per complaint ratio calculation this incident seems to be rare to happen.This line of product has a compatibility test and result (b)(4) on file.This complaint will be monitored for trending purposes and has been added to the related logs and charts.

• Brand Name: NEOTECH PRODUCTS
• Common Device Name: NEOLEAD
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 witherspoon parkway; valencia, CA 91355 ; 6617757466
• MDR Report Key: 15442269
• Report Number: 2025917-2022-00010
• Device Sequence Number: 14607928
• Product Code: DRX
• UDI-Device Identifier: 00812594011054
• UDI-Public: 00812594011054
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A#S-P#N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2025
• Device Model Number: N301
• Device Catalogue Number: N301
• Device Lot Number: 2022-9003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown