MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STRIP,CLOSURE,WOUND,MEDI-STRIP,1/4X3

Catalog Number	NON250314
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when applying this tape, it is causing blisters on patients.Also they are having issues with the tape not sticking.
Additional Manufacturer Narrative
The customer reported that when applying this tape, it is causing blisters on patients, and they are having issues with the tape not sticking.The provided photos were reviewed, the provided samples were evaluated, the vendor was notified of the issue and sent the provided samples, and trend analysis was performed by reviewing the past two years of complaint data.The reported issue was confirmed; however, medline could not confirm that the product failed to meet specifications, and no product defects were identified as a result of the sample evaluation.A review of the complaint information as well as the results of the investigation indicate no need for further action at this time, and a divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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: STRIP,CLOSURE,WOUND,MEDI-STRIP,1/4X3
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754865
• Report Number: 1417592-2026-39309
• Device Sequence Number: 9550437
• Product Code: KGX
• UDI-Device Identifier: 20080196691859
• UDI-Public: 20080196691859
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: NON250314
• Device Lot Number: 471067
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2025
• 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: 12/05/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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