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

Model Number	N305 AND N306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Skin reaction.
Additional Manufacturer Narrative
This is our response to reports sent to us by fda and filed by (b)(6) hospital.(4900240000-2023-8068, 8060, 8058, 8057, 8047, 8046, 8045, 8035).We have reviewed the incidents and sought input from our quality, regulatory and clinical consultant teams.Retained samples have been inspected and no anomalies or conformities issues have been identified.We have been unable to identify a definitive cause for the patients' skin reaction.Possible causes that cannot be ruled out include acrylic skin sensitivity, hyper-reactivity to adhesive materials due to an immature immune system, and/or maceration of the skin caused by exposure to excessive moisture from the environmental humidity or from bathing.We have recalculated our complaint rate, including these, and the rate remains less than 0.005%.Which means that this experience is exceedingly rare.We have also added these incidents to our internal tracking system.We will continue to monitor event reports in the future and identify any developing trends that may require additional action.We are constantly looking for ways to improve our products and processes, and to that end, this feedback is valuable to us.

• Brand Name: NEOTECH PRODUCTS
• Common Device Name: NEOLEAD
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 whiterspoon parkway; valencia CA 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 whiterspoon parkway; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 whiterspoon parkway; valencia 91355 ; 6617757464
• MDR Report Key: 17011221
• Report Number: 2025917-2023-00001
• Device Sequence Number: 12494723
• Product Code: DRX
• UDI-Device Identifier: 00812594010293
• UDI-Public: 00812594010293
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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 Model Number: N305 AND N306
• Device Catalogue Number: N305 AND N306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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