MAUDE Adverse Event Report: Medline Industriess, LP MEDLINE; OPTIFOAM GENTLE EX, BORDERED, 3X3

Catalog Number	MSCEX33EPZ
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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that adhesive does not adhere to skin, may not have any adhesive at all.
Additional Manufacturer Narrative
The customer reported an adhesive issue with optifoam gentle ex, bordered, 3x3; complaint details stated, "adhesive does not adhere to skin, may not have any adhesive at all." the supplier/quality team was notified, and a formal investigation was completed; the vendor reviewed dhr and batch records, inspection records, manufacturing process, raw material quality, equipment calibration and preventive maintenance, employee training, and retain sample review, and all were found to meet the required specifications.The reported issue regarding "doesn't seal/adhere well" could not be confirmed as no sample was received for investigation.Without a sample for evaluation, medline was unable to confirm the issue or determine a potential root cause, and a review of the complaint information as well as the results of the investigation indicated no need for further action 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, 3X3
• Manufacturer (Section D): Medline Industriess, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897935
• Report Number: 1417592-2026-50938
• Device Sequence Number: 10712274
• Product Code: NAD
• UDI-Device Identifier: 10888277652620
• UDI-Public: 10888277652620
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/24/2026

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: MSCEX33EPZ
• Device Lot Number: RX33724
• 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: 07/22/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown