BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-SURGICAL LEVEL 3 ISOLATION GOWNS

    MDR report key: 12738088 · Received November 1, 2021

    Report

    Report Number
    MW5105075
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 28, 2021
    Report Date
    October 29, 2021
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FIRE-DEX NON-SURGICAL LEVEL 3 ISOLATION GOWN DOES NOT HAVE TAPING ON THE SEAMS THAT PREVENTS BIOHAZARDOUS FLUIDS FROM PASSING THROUGH THE SEAMS. FIRE-DEX ADVERTISES THIS GOWN AS MEETING THE AATCC 42 AND AATCC 127 TESTS. AFTER FURTHER INVESTIGATION AND TESTING, THIS GOWN DOES NOT MEET THESE TWO TESTS SINCE THE SEAMS ARE NOT COVERED (TAPED) WITH A MATERIAL THAT PREVENTS BIOHAZARDOUS FLUIDS FROM PASSING THROUGH. BY FAILING THESE TWO INDUSTRY STANDARD TESTS, IT CONCLUDES THAT FIRE-DEX IS FALSELY ADVERTISING AND MARKETING THIS PRODUCT AS A AAMI LEVEL 3 ISOLATION GOWN. PLEASE NOTE THAT MANY OF THESE GOWNS HAVE BEEN SOLD TO FIRE RESPONDERS AROUND THE UNITED STATES UNDER THE FALSE PRETENSE THAT THE SEAMS WILL BLOCK BIOHAZARDOUS FLUIDS FROM PASSING THROUGH. THIS ITEM WILL NOT OFFER ANY PROTECTION TO THE PERSON WEARING THE GOWN IN THE SEAM AREA AND WILL CONTAMINATE THE PERSON WEARING THE GOWN. I AM NOTIFYING THE FDA, SO A RECALL CAN BE ISSUED AS SOON AS POSSIBLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632416 NON-SURGICAL LEVEL 3 ISOLATION GOWNS NON-SURGICAL ISOLATION GOWN OEA MC311

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R