MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIFOAM GENTLE EX, BORDERED, 4X4

Catalog Number	MSCEX44EP
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	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these 2 bx are not staying on well.They are peeling off right away and won't stick.She believes the box has a defect.".
Additional Manufacturer Narrative
The customer reported issue "will not stick" with optifoam gentle ex, bordered, 4x4, and stated the boxes were "peeling off right away" and "won't stick." vendor/manufacturer reviewed batch product records, batch analysis record review coa, retain sample, inspection records regarding stickiness, production records and machine setting records, and the test result of adhesion meet the specification.The reported issue could not be confirmed as no sample was received for investigation; when a sample picture was received, the issue cannot be determined as the sample is missing the product.Without the sample to evaluate, medline was unable to confirm the complaint or identify a potential root cause, and no corrective and preventive action is deemed necessary 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: OPTIFOAM GENTLE EX, BORDERED, 4X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916051
• Report Number: 1417592-2026-52094
• Device Sequence Number: 5753142
• Product Code: NAD
• UDI-Device Identifier: 10888277652637
• UDI-Public: 10888277652637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/25/2026

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: MSCEX44EP
• Device Lot Number: RX18524
• 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: 01/15/2025
• Initial Report FDA Received Date: 09/28/2026
• 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