MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; FIBER, MEDICAL, ABSORBENT

Model Number	MDT2168304
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While placing sterile drapes for a total joint surgery, dr.Noticed a piece of light brown fuzz between the folds of a sterile towel.The towel was immediately removed from the sterile field.The surgery proceeded as planned.

• Brand Name: MEDLINE
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 24686863
• Report Number: 24686863
• Device Sequence Number: 13193284
• Product Code: FRL
• UDI-Device Identifier: 20888277653617
• UDI-Public: (01)20888277653617
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/16/2026
• Report Date (Section F): 03/16/2026

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
• Device Model Number: MDT2168304
• Device Catalogue Number: MDT2168304
• Device Lot Number: 6052510012VN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• 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 Age: 71 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/16/2026