MAUDE Adverse Event Report: RESOURCE OPTIMIZATION & INNOVATION, LLC REGARD; AAMI LEVEL 3 SURGICAL GOWN, REINFORCED SMS, STERILE X LARGE

Model Number	A3ISRGSTXL-REG
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Gown was donned by scrub tech during surgical case.The individual noticed that her scrubs felt damp against her skin where the outside of the gown had blood castoff from procedure.Upon removal of the gown, scrub tech discovered that her scrubs had blood soaked onto them from the outside of the gown.
Additional Manufacturer Narrative
The oem for the aami level 3 gown reported in this event was engaged to investigate any potential root causes of the reported event related to the manufacturing of the gown.The capa is attached to this record.

• Brand Name: REGARD
• Common Device Name: AAMI LEVEL 3 SURGICAL GOWN, REINFORCED SMS, STERILE X LARGE
• 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; saint louis MO 63141
• Manufacturer Contact: cheyenne stewart ; 645 maryville centre drive; saint louis 63141 ; 8558459302
• MDR Report Key: 20304803
• Report Number: 3004513970-2024-00001
• Device Sequence Number: 7744602
• Product Code: FYA
• UDI-Device Identifier: 00326053117756
• UDI-Public: 326053117756
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: A3ISRGSTXL-REG
• Device Catalogue Number: A3ISRGSTXL-REG
• Device Lot Number: 20K206H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown