BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD

    MDR report key: 16655442 · Received March 31, 2023

    Report

    Report Number
    3004513970-2023-00001
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 30, 2023
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE REGARD AAMI LEVEL 3 GOWN THAT THE PHYSICIAN WAS WEARING ALLOWED FLUIDS TO PENETRATE THROUGH TO HER CLOTHING/SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059662 REGARD NON-REINFORCED GOWN, AAMI LEVEL 3 FYA RESOURCE OPTIMIZATION & INNOVATION, LLC A3SRGSTL-REG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown