MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GAUZE/SPONGE, INTERNAL

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2023

Event Type  malfunction  

Event Description

Small blue strip on codman 0.5x0.5 neuro patties that come inside the crani pack kit.After getting all 10 patties off the field, one pattie was noted to be missing the blue strip and was unable to be found.

• Brand Name: DEROYAL
• Type of Device: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln; powell TN 37849
• MDR Report Key: 16408069
• MDR Text Key: 309895724
• Report Number: 16408069
• Device Sequence Number: 1
• Product Code: EFQ
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female