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

Catalog Number 59-10568-03

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

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Upon opening a pacemaker kit ref #59-10568-03 - a small piece of black fuzz was discovered in the bowl when liquid was dispensed into the bowl.This pack was discarded as contaminated.

• Brand Name: DEROYAL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES INC.; 200 debusk ln; powell TN 37849
• MDR Report Key: 14117726
• MDR Text Key: 289336131
• Report Number: 14117726
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 59-10568-03
• Device Lot Number: 56619558
• 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: 03/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1