MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPNG-1/2X1"-STRL- 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-055
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, " when using the neuro sponges ref 30-055 lot 24112874 exp 12/11/2029 the product, which is supposed to be x-ray detectable was not detected on the xray." deroyal industries, inc.Requested return of the device, but has not yet been received.A supplier corrective action request (scar) will be issued to the supplier/manufacturer, medsorb dominicana.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "when using the neuro sponges ref 30-055 lot 24112874 exp 12/11/2029 the product, which is supposed to be x-ray detectable was not detected on the xray.".

• Brand Name: NEURO SPNG-1/2X1"-STRL- 20/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23876853
• Report Number: 1060680-2025-00055
• Device Sequence Number: 21245172
• Product Code: EFQ
• UDI-Device Identifier: 50749756037407
• UDI-Public: 50749756037407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 30-055
• Device Lot Number: 24112874
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown