MAUDE Adverse Event Report: OPERATING ROOM INNOVATIONS, INC, SOLOFIT GOWN; SURGICAL GOWN

Model Number	SF-4XL-ELB
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This issue was investigated and determined to be an isolated quality manufacturing issue in which other product sampled from this lot did not exhibit the missing component.
Event or Problem Description
One solofit gown which was recently manufactured lot 2406e499 (june 2024) was opened and used in surgery, a sales representative of manufacturer's distributor was there and noticed that one of the surgical gowns was missing a velcro strap on the shoulder of the gown after the surgery was completed.This issue could result in the gown not meeting its intended use to protect and provide a barrier for surgical personnel to be protected against contamination and/or exposure of infectious bodily fluids and harmful microorganisms.If velcro is missing, then it is possible that the gown could loosen and might interrupt user in middle of surgical procedure if the surgical gown falls off or down the user's shoulder.

• Brand Name: SOLOFIT GOWN
• Common Device Name: SURGICAL GOWN
• Manufacturer (Section D): OPERATING ROOM INNOVATIONS, INC,; 2223 avenida de la playa; ste 104; la jolla CA 92037 3217
• Manufacturer Contact: susan qualey ; 2223 avenida de la playa; ste 104; la jolla, CA 92037-3217 ; 6192100725
• MDR Report Key: 23856499
• Report Number: 3017838287-2025-00001
• Device Sequence Number: 21426368
• Product Code: FYA
• UDI-Device Identifier: 06975085708742
• UDI-Public: (01)06975085708742(17)290610(10)2406E499
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200977
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: Health Professional
• Device Model Number: SF-4XL-ELB
• Device Catalogue Number: SF-4XL-ELB
• Device Lot Number: 2406E499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown