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

Model Number 89-3159

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

A hair found in tray.

• Brand Name: DEROYAL PACEMAKER TRAY
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 16572042
• MDR Text Key: 311573058
• Report Number: 16572042
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 89-3159
• Device Lot Number: 58043062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2023
• Date Report to Manufacturer: 03/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1