MAUDE Adverse Event Report: RESOURCE OPTIMIZATION & INNOVATION, LLC REGARD; NON-REINFORCED GOWN, AAMI LEVEL 3

Model Number A3SRGSTL-REG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

The regard aami level 3 gown that the physician was wearing allowed fluids to penetrate through to her clothing/skin.

• Brand Name: REGARD
• Type of Device: NON-REINFORCED GOWN, AAMI LEVEL 3
• Manufacturer (Section D): RESOURCE OPTIMIZATION & INNOVATION, LLC; 645 maryville centre drive; suite 200; saint louis MO 63141
• Manufacturer (Section G): RESOURCE OPTIMIZATION & INNOVATION, LLC; 645 maryville centre drive; suite 200; saint louis MO 63141
• Manufacturer Contact: cheyenne stewart ; 645 maeybille centre drive; suite 200; saint louis, MO 63141 ; 4176473205
• MDR Report Key: 16655442
• MDR Text Key: 312461728
• Report Number: 3004513970-2023-00001
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A3SRGSTL-REG
• Device Catalogue Number: A3SRGSTL-REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1