MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY

Model Number	89-2580
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Deroyal small general pack -- note says that there was not ruler in the pack.Unsure the date of event or planned procedure.

• Brand Name: DEROYAL
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 23582179
• Report Number: 23582179
• Device Sequence Number: 15802190
• Product Code: LRO
• UDI-Device Identifier: 50749756281411
• UDI-Public: (01)50749756281411
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/23/2025
• Report Date (Section F): 10/23/2025

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
• Device Model Number: 89-2580
• Device Lot Number: 62457410
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/23/2025