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

Model Number	89-4393
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The surgical team opened a chronic ear pack for a procedure.Inside were 10 4x4 x-ray detectable sponges wrapped with a paper band, as usual, but there was also a loose 4x4 x-ray detectable sponge loose in the basin.

• Brand Name: DEROYAL
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13807805
• Report Number: 13807805
• Device Sequence Number: 19347639
• Product Code: LRO
• UDI-Device Identifier: 00749756585750
• UDI-Public: (01)00749756585750
• 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): 03/03/2022
• Report Date (Section F): 03/03/2022

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: 89-4393
• Device Lot Number: 54854757
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/03/2022