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

Model Number	30-060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the surgeon was using 1'x3" cottonoids during a craniectomy and the radiopaque strip on the cottonoid that wasn't sewn onto the cottonoid and kept peeling off of the cottonoid and into the patient.Two of the cottonoids had peeled off and the surgeon handed nurse the strips back and the nurse made sure they were not missing any strips from the other cottonoids that we had used during the case.The nurse then laid all of the cottonoids with the strips that had come off to verify that all pieces were retrieved and not lost.Action taken: the product used was identified as lot number 2410700.As a precautionary measure, the assistant nurse manager removed all affected lot 2410700 from circulation.They also conducted an inspection of other deroyal neuro sponge lots currently in stock.All remaining inventory was found to be intact, with no issues observed.The event, concerns, and the necessary precautions were communicated to the or team, and they were advised on what to look out for.Additionally, materials management was informed of the issue.Or was advised to discard all deroyal 1x3 neuro sponges, as there is an alternative manufacturer¿s product available in stock.

• Brand Name: DEROYAL NEURO SPONGES
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln; powell TN 37849
• MDR Report Key: 22737631
• Report Number: 22737631
• Device Sequence Number: 7218463
• Product Code: EFQ
• UDI-Device Identifier: 00749756037785
• UDI-Public: (01)00749756037785
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025
• Report Date (Section F): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30-060
• Device Catalogue Number: 30-060
• Device Lot Number: 2410700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/02/2025