MAUDE Adverse Event Report: Medline Industries, LP Medline; FIELD,STERILE,TISSUE-POLY-TISS,18X26

Catalog Number	NON21003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: Medline
• Common Device Name: FIELD,STERILE,TISSUE-POLY-TISS,18X26
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805713
• Report Number: 1417592-2026-10106
• Device Sequence Number: 18291914
• Product Code: PUI
• UDI-Device Identifier: 10080196746248
• UDI-Public: 10080196746248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: NON21003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male