MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,ADHESIVE,FABRIC,1"X3",STRL,LF

Catalog Number	NON25660
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Skin Tears (2516)
Date of Event	09/24/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: BANDAGE,ADHESIVE,FABRIC,1"X3",STRL,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50747619
• Report Number: 1417592-2026-38704
• Device Sequence Number: 16011435
• Product Code: KGX
• UDI-Device Identifier: 40080196692799
• UDI-Public: 40080196692799
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Catalogue Number: NON25660
• Device Lot Number: 90922100001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/13/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Female