MAUDE Adverse Event Report: JIANGSU SHUANGIONGJIAN ARMENT CO. LTD ADAPTIVE ENERGY ISOLATION GOWN POLYESTER ISOLATION CODE; NON-SURGICAL ISOLATION GOWN

Model Number G20049580

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2021

Event Type  Injury  

Event Description

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).

• Brand Name: ADAPTIVE ENERGY ISOLATION GOWN POLYESTER ISOLATION CODE
• Type of Device: NON-SURGICAL ISOLATION GOWN
• Manufacturer (Section D): JIANGSU SHUANGIONGJIAN ARMENT CO. LTD; rucheng town rugao, jiangsu 22650 0 CN; CH 226500 CN
• MDR Report Key: 12275364
• MDR Text Key: 265179513
• Report Number: MW5102950
• Device Sequence Number: 1
• Product Code: OEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Model Number: G20049580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening