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

Model Number 89-3564

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

1/2" x 1/2" surgical patties supplied in the lumbar laminectomy pack have a blue x-ray detectable strip which detached from the patty.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13257688
• MDR Text Key: 283824515
• Report Number: 13257688
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756559270
• UDI-Public: (01)00749756559270
• 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: 12/03/2021

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 Operator: Health Professional
• Device Model Number: 89-3564
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Sex: Male
• Patient Weight: 89 KG