MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. NEURO SPGS-1/2X6"-20/C; GAUZE/SPONGE, INTERNAL

Model Number	30-301
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reporting through a medwatch, "there were 11 (1/2 x 6) neuro strips in a package when there should have been 10.This is an item used in surgery that is counted.".
Additional Manufacturer Narrative
A user facility reported through a medwatch report, "there were 11 (1/2 x 6) neuro strips in a package when there should have been 10.This is an item used in surgery that is counted." deroyal industries, inc.Requested return of the device, however it was stated that it was unavailable for return.A supplier corrective action request (scar) was issued to the supplier, (b)(4).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.

• Brand Name: NEURO SPGS-1/2X6"-20/C
• 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: 24605210
• Report Number: 1060680-2026-00006
• Device Sequence Number: 9027267
• Product Code: EFQ
• UDI-Device Identifier: 50749756037858
• UDI-Public: 50749756037858
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/17/2026

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: 30-301
• Device Lot Number: 25041328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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