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

Catalog Number 89-10552.01

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

Hair found within surgical pack.The hair was found between the drape/sheets and mayo cover within the pack.The hair was described as black and about 1-1.5 inches long.The sterile field was taken down and discarded then reset.Pack and hair not saved.

• Brand Name: EXTREMITY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 10648368
• MDR Text Key: 210401799
• Report Number: 10648368
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 89-10552.01
• Device Lot Number: 52805142
• 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: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA