MAUDE Adverse Event Report: RESOURCE OPTIMIZATION & INNOVATION, LLC REGARD; SURGICAL N95 PARTICULATE RESPIRATOR

Model Number	N95SRGRESP-REG
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The facility reported that their staff had not been fit tested for the masks prior to use as required.This is likely a contributing factor to the concerns raised by the users.Additionally, roi provides donning and doffing instructions to aide in proper use of the masks.The instructions were not used or followed prior to use.
Event or Problem Description
The customer reported that team members and providers are concerned with the product quality stating that it is flimsy and does not seal to their face appropriately due to strap design.Staff also raised concern that they were not fit tested for the mask prior to donning and use.

• Brand Name: REGARD
• Common Device Name: SURGICAL N95 PARTICULATE RESPIRATOR
• Manufacturer (Section D): RESOURCE OPTIMIZATION & INNOVATION, LLC; 1100 dr. martin l. king jr.; blvd. suite 1100; nashville TN 37203
• Manufacturer (Section G): RESOURCE OPTIMIZATION & INNOVATION, LLC; 1100 dr. martin l. king jr.; blvd., suite 1100; nashville TN 37203
• Manufacturer Contact: cheyenne stewart ; 1100 dr. martin l. king jr blvd, suite 1100; nashville, TN 37203
• MDR Report Key: 25115688
• Report Number: 3004513970-2026-00001
• Device Sequence Number: 10279826
• Product Code: MSH
• UDI-Device Identifier: 10326053123457
• UDI-Public: (01)10326053123457
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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
• Operator of Device: Health Professional
• Device Model Number: N95SRGRESP-REG
• Device Catalogue Number: N95SRGRESP-REG
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown