MAUDE Adverse Event Report: Medsorb Dominicana, S.A. NEURO-SP-1/2X1/2"-STRL 20/CS; GAUZE/SPONGE, INTERNAL

Model Number	30-054
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: NEURO-SP-1/2X1/2"-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 ; +1(865)362-2106
• MDR Report Key: 50846094
• Report Number: 1060680-2026-00016
• Device Sequence Number: 9957727
• Product Code: EFQ
• UDI-Device Identifier: 00749756037242
• UDI-Public: 00749756037242
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 30-054
• Device Lot Number: 25093139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/21/2026
• 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