BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AAMI LEVEL 3 ISOLATION GOWN & COVERALL

    MDR report key: 10918724 · Received November 25, 2020

    Report

    Report Number
    MW5098118
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    November 24, 2020
    Manufacturer
    FIRE-DEX, LLC
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS TO NOTIFY THE FDA THAT THE AAMI LEVEL 3 ISOLATION GOWN AND COVERALL MANUFACTURED BY FIRE-DEX IS NOT ACTUALLY COMPLIANT TO THE AAMI LEVEL 3 STANDARD. FIRE-DEX UTILIZES A MATERIAL (STEDAIR MEDICAL) THAT IS TESTED TO THE AAMI LEVEL 3 STANDARD AND THE ACTUAL GOWN AND COVERALL IS NOT THIRD PARTY TESTED AFTER BEING MADE OR SEWN. ALSO NOTE, THAT THE SEAMS OF THE GOWN AND COVERALL ARE NOT TAPED OR COVERED WITH A MOISTURE BARRIER MATERIAL TO PREVENT CONTAMINATED FLUIDS FROM PASSING THROUGH. BY NOT USING A MOISTURE BARRIER MATERIAL TO COVER THE SEAMS, THE WEARER COULD BECOME CONTAMINATED BY FLUIDS PASSING THROUGH THE HOLES OF THE SEAMS AND THIS WOULD NOT PASS THE THIRD PARTY AAMI TESTS. THIS VIOLATES THE CDC GUIDELINE SET FORTH FOR LEVEL 3 ISOLATION GOWNS AND DOES NOT MEET THE ANSI, AAMI AND NFPA 1999 STANDARDS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372291 AAMI LEVEL 3 ISOLATION GOWN & COVERALL NON-SURGICAL ISOLATION GOWN OEA FIRE-DEX, LLC MG311
    1372292 AAMI LEVEL 3 ISOLATION GOWN & COVERALL NON-SURGICAL ISOLATION GOWN OEA FIRE-DEX, LLC MC311

    Patients

    Seq Age Sex Outcome Treatment
    1