MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIFOAM GENTLE EX, BORDERED, 6X6

Catalog Number	MSCEX66EP
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported issue with the item sticking to a scab when not supposed to be with item optifoam gentle ex, bordered, 6x6.The customer did not provide a sample, the supplier was asked to investigate the lot reported, and questions were relayed to the customer for further investigation; however, no response was received.The complaint could not be confirmed; cause was documented as "sample required to determine cause." trending was reviewed and there have been no additional complaints for this item in the last 24 months; the complaint rate is 0%, and the division will continue to monitor trending through the quarterly trend reports.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.
Event or Problem Description
It was reported that "sticking to scab when its not supposed to be".

• Brand Name: MEDLINE
• Common Device Name: OPTIFOAM GENTLE EX, BORDERED, 6X6
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50551851
• Report Number: 1417592-2026-30184
• Device Sequence Number: 21483032
• Product Code: NAD
• UDI-Device Identifier: 30888277652648
• UDI-Public: 30888277652648
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/01/2026

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: MSCEX66EP
• Device Lot Number: RX23722
• 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: 08/17/2023
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown