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

Model Number 89-4393

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event 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
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13807805
• MDR Text Key: 287405215
• Report Number: 13807805
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756585750
• UDI-Public: (01)00749756585750
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1