MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GAUZE,BORDER,4"X14",(2X12"PAD,)STERILE

Catalog Number	MSC32414
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Peeling (1999); Blister (4537)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GAUZE,BORDER,4"X14",(2X12"PAD,)STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50847147
• Report Number: 1417592-2026-47072
• Device Sequence Number: 9508513
• Product Code: NAD
• UDI-Device Identifier: 10080196743087
• UDI-Public: 10080196743087
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/21/2026

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: MSC32414
• 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: 09/29/2025
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown