MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOBAR

Model Number	N710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual examination of the returned device did not identify any evidence of pre-existing physical damage, material defects, or product abnormality that could have contributed to the reported event.The t-bars remained properly affixed to the tab's non-woven fabric with no observed separation, deformation, or structural irregularity.The device tabs exhibited signs of normal wear and tear consistent with expected use and removal from patient skin.No sharp edges, fractures, exposed components, adhesive inconsistencies, or t-bar abnormalities were observed during evaluation.Based on the clinical information provided and the investigation performed on the returned product, no device-related malfunction or manufacturing nonconformance was identified that would reasonably be expected to result in the reported skin issue.The reported condition appears more consistent with use-related and patient-specific factors, including potential skin sensitivity and/or clinical application conditions (e.G., skin preparation practices, or nicu monitoring environment).Based on the complaint ratio, this type of incident is rare.The complaint will be monitored for trending purposes and has been documented in the appropriate logs and charts.
Event or Problem Description
Skin reaction just on right cheek.

• Brand Name: NEOBAR
• Common Device Name: NEOBAR
• 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 91355 ; 6617757466
• MDR Report Key: 25339521
• Report Number: 2025917-2026-00002
• Device Sequence Number: 18638379
• Product Code: CBH
• UDI-Device Identifier: 00812594011078
• UDI-Public: 00812594011078
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: N710
• Device Catalogue Number: N710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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