MAUDE Adverse Event Report: JOINTOWN MEDICAL DEVICES GROUP CO., LTD ARUIKON; GOWN, SURGICAL

Lot Number 20200628

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Gown failure.Cleaning chemical permeated aruikon disposable medical protective coverall, and contacted the skin of an employee.

Event Description

Gown failure.Cleaning chemical permeated aruikon disposable medical protective coverall, and contacted the skin of an employee.

• Brand Name: ARUIKON
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): JOINTOWN MEDICAL DEVICES GROUP CO., LTD; 2215 alcazar st; los angeles CA 90033
• MDR Report Key: 11841066
• MDR Text Key: 251130956
• Report Number: 11841066
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20200628
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Date Report to Manufacturer: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1