BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTIVE ENERGY ISOLATION GOWN POLYESTER ISOLATION CODE

    MDR report key: 12275364 · Received August 3, 2021

    Report

    Report Number
    MW5102950
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 29, 2021
    Report Date
    July 30, 2021
    Manufacturer
    JIANGSU SHUANGIONGJIAN ARMENT CO. LTD
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE ISOLATION GOWNS USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): POLYESTER ISOLATION GOWNS 700 PIECES PRODUCTION DATE 5/13/2020, EXPIRES: 5/12/2022. DISPOSABLE DO NOT REUSE. DISTRIBUTED BY: (B)(4). MANUFACTURER: JIANGSU SHUANGLONGJIAN ARMENT CO., LTD. PRODUCTION ADDRESS: (B)(4). PRODUCTION NUMBER: (B)(4). MADE IN (B)(4). PROBLEM WITH PPE FOR ALL STAFF USING IT, MAY CAUSE CONTAMINATION DURING DOFFING STAGE R/T DIFFICULTY GETTING THE GOWN OFF, LEAVING HANDS, WRISTS, NECK, FACE, HAIR VULNERABLE TO EXPOSURE TO COVID19 VIRUS. TRAINING HAS BEEN GIVEN, PROBLEM IS WITH THE PRODUCT BEING UNSAFE TO USE AS PPE DURING THIS PANDEMIC. IT MAY BE ADEQUATE AS A BARRIER FOR ENVIRONMENTAL CLEANING IN AN AREA WITH DUST AND DIRT CONTAMINANTS BUT NOT COVID19. ADDITIONAL TRAINING FOR USE OF THESE GOWNS HAS NOT REDUCED RISK OF EXPOSURE TO COVID19. THE GOWNS ARE NOT ADEQUATE PPE PROTECTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166284 ADAPTIVE ENERGY ISOLATION GOWN POLYESTER ISOLATION CODE NON-SURGICAL ISOLATION GOWN OEA JIANGSU SHUANGIONGJIAN ARMENT CO. LTD G20049580

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening