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

Model Number	N420
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; therefore, no evaluation could be conducted on the actual unit.Retained samples from the current inventory of all three catalog numbers and their respective device history records (dhrs), were reviewed, and no issues were identified.As the manufacturer, we have taken extensive steps to mitigate the risk of such incidents.This specific risk is clearly outlined in our directions for use, where we emphasize the necessity of direct supervision by trained healthcare professionals.The caution is also clearly printed on the back of the device liner.Furthermore, we have specifically advised that any placement, removal, or replacement of the device must be documented in the patient's medical records, which is essential for traceability and patient safety.Proper use and documentation by the end user are critical.Had the outlined procedures been followed, not only would the product details (e.G., part and lot numbers) have been readily accessible, but it is likely that the incident could have been prevented altogether.We kindly ask and reemphasize to our customers and end users the importance of carefully reviewing and adhering to all provided instructions, particularly the cautions and warnings.Doing so ensures the highest standard of safety for patients and supports effective incident management should any issues arise.This incident has been logged and will be monitored for trending purposes.
Event or Problem Description
Infant ingested one of these items.

• Brand Name: NEOTECH PRODUCTS
• Common Device Name: NEOSEAL
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 whiterspoon pkwy; valencia CA 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 whiterspoon parkway; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 whiterspoon parkway; valencia, CA 91355 ; 6617757464
• MDR Report Key: 22613245
• Report Number: 2025917-2025-00003
• Device Sequence Number: 5384068
• Product Code: BXJ
• UDI-Device Identifier: 10812594012164
• UDI-Public: 10812594012164
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N420
• Device Catalogue Number: N420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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