BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 25115688 · Received May 7, 2026

    Report

    Report Number
    3004513970-2026-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    MSH
    UDI-DI
    10326053123457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599458 REGARD SURGICAL N95 PARTICULATE RESPIRATOR MSH RESOURCE OPTIMIZATION & INNOVATION, LLC N95SRGRESP-REG 10326053123457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown