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

Model Number 89-10571

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Event Description

During setup hair found inside big wrapped round blue basin inside the pack.Wrapped basin was discarded.The rest of the setup was considered not contaminated.No items saved.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 12016364
• MDR Text Key: 256724499
• Report Number: 12016364
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-10571
• Device Catalogue Number: 89-10571
• Device Lot Number: 53332666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1