MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GAUZE, BORDER, 3"X6", 1.5"X4"PAD, STERIL

Catalog Number	MSC3236
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿per caller- skin reaction to the dressing (been using for 5 days) very irritated, getting a rash and skin break down.¿.
Additional Manufacturer Narrative
The customer reported a ¿skin reaction to the dressing (been using for 5 days)¿ and stated that ¿by day 4, there was redness and sores all around where the tape was around one incision and extreme redness where the tape was around second incision.¿ a review was conducted of irritation and skin sensitization testing and product specification evaluation, and all scar and capa records for the division were reviewed; photo received was no, sample received was no, and picture/sample evaluation was no.In the absence of a physical sample or high-quality, detailed photos, medline was unable to confirm the presence of a defect during this investigation.With the information provided, medline cannot confirm the reported issue, and a review of the complaint information as well as the results of the investigation indicate no need for further action at this time.There were no reports of death, serious injury, medical intervention, or follow up care.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: GAUZE, BORDER, 3"X6", 1.5"X4"PAD, STERIL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50694078
• Report Number: 1417592-2026-34979
• Device Sequence Number: 13160694
• Product Code: NAD
• UDI-Device Identifier: 30888277678976
• UDI-Public: 30888277678976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/09/2026

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: MSC3236
• Device Lot Number: 87525070009
• 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: 12/19/2025
• Initial Report FDA Received Date: 09/09/2026
• 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 Age: 74 YR
• Patient Sex: Male