MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SILICONE FABRIC ADH BNDG 3/4X3

Catalog Number	NON75100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the silicone fabric does not stick.
Additional Manufacturer Narrative
The customer reported that all of those given the bandages complained that "they do not stick" on "clean, dry skin - no stick." a physical sample of the product was not received, and the reported issue involves a functional characteristic of the product, which cannot be fully evaluated or verified without examination of the actual product.Due to these limitations, the complaint could not be confirmed, and a definitive root cause for the reported condition could not be established.No new information, failure modes, or trends were identified that would warrant revision of the complaint classification.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: SILICONE FABRIC ADH BNDG 3/4X3
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50778640
• Report Number: 1417592-2026-41382
• Device Sequence Number: 9825860
• Product Code: NAC
• UDI-Device Identifier: 30888277677757
• UDI-Public: 30888277677757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: NON75100
• Was Device Available for Evaluation?: No
• 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: 01/04/2023
• Initial Report FDA Received Date: 09/15/2026
• 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