MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE INDUSTRIES; SPONGE,NEURO,0.5,XR,STRL,10/PK

Catalog Number	NEUROSPNG05
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erythema (1840); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following a 'left lumbar 4-lumbar 5 microdiscectomy" on (b)(6) 2026 where the neurosponges were used the " patient continues to healing issues.The customer reported "persistant drainage , fluid collection subconsciously and wound open back up" as well as erthima along incision site ".

• Brand Name: MEDLINE INDUSTRIES
• Common Device Name: SPONGE,NEURO,0.5,XR,STRL,10/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; north field 60093 2753
• Manufacturer Contact: m latha ; three lake drive; north field 60093
• MDR Report Key: 25510241
• Report Number: 1417592-2026-90082
• Device Sequence Number: 10520338
• Product Code: HBA
• UDI-Device Identifier: 20080196286659
• UDI-Public: 20080196286659
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NEUROSPNG05
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown