MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING, CONTACT LAYER, VERSATEL, 3X4

Catalog Number	MSC1734EP
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	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the item is not as sticky as it normally should be" and "the product didn't stick as it should.".
Additional Manufacturer Narrative
The customer reported that the contact layer "must be sticky to adhere over the wound and skin sub" and that when staff applied it, "the product didn't stick as it should." medline confirmed the reported issue of "not sticking" with the received sample or photo, and the vendor/manufacturer reviewed dhr and batch record, inspection record, manufacturing, raw material and equipment calibration and preventive maintenance, employee training, and retain sample; the vendor also checked the production record and tested peeling strength of retained samples and received samples.The investigation documented that records and retain samples met the specification as required, no abnormality was found, and the testing results were all within the standard, with cause coded as "not confirmed with received sample." no root cause was identified; the adhesive is designed to be not too sticky, and the division will continue to monitor trending through quarterly trend reports with no change to the reportability decision.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: DRESSING, CONTACT LAYER, VERSATEL, 3X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868127
• Report Number: 1417592-2026-48686
• Device Sequence Number: 16124942
• Product Code: NAD
• UDI-Device Identifier: 40884389150994
• UDI-Public: 40884389150994
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/22/2026

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: MSC1734EP
• Device Lot Number: 27924030016
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2025
• 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: 12/02/2024
• Initial Report FDA Received Date: 09/23/2026
• 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