MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TOWEL,OR,DSP,ST,BLUE,HEAVY,4/PK,20PK/CS

Catalog Number	MDT2168304
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Lint from an operating room towel went into a patient's eye during a surgical procedure.
Additional Manufacturer Narrative
Lint from an operating room towel went into a patient's eye during a surgical procedure.The patient had to be taken back to the operating room to remove it.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Common Device Name: TOWEL,OR,DSP,ST,BLUE,HEAVY,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 22441022
• Report Number: 1417592-2025-00328
• Device Sequence Number: 15602894
• Product Code: FRL
• UDI-Device Identifier: 10888277653610
• UDI-Public: 10888277653610
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: MDT2168304
• Device Lot Number: 6052408005
• 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: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown