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

Model Number	89-3865.13
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
As she was covering the mayo stand with the mayo stand cover from the pack it was noted that the end of the mayo stand cover was open instead of being sealed, thus the scrub inadvertently contaminated herself in the process of placing the mayo stand cover on the mayo stand.

• Brand Name: DEROYAL
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 9615709
• Report Number: 9615709
• Device Sequence Number: 2721290
• Product Code: LRO
• UDI-Device Identifier: 00749756568043
• UDI-Public: (01)00749756568043
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/02/2020
• Report Date (Section F): 01/02/2020

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: 89-3865.13
• Device Lot Number: 50905406
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/02/2020