MAUDE Adverse Event Report: MEDLINE INDUSTRIED LP MEDLINE; OPTIFOAM GENTLE,NON-BORDERED,4X4

Catalog Number	MSC2244EP
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	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported "customer called in to report they are not sticking at all after 2 days they fall off." 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.
Event or Problem Description
It has been reported "customer called in to report they are not sticking at all after 2 days they fall off.".

• Brand Name: MEDLINE
• Common Device Name: OPTIFOAM GENTLE,NON-BORDERED,4X4
• Manufacturer (Section D): MEDLINE INDUSTRIED LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 25523569
• Report Number: 1417592-2026-02477
• Device Sequence Number: 13401308
• Product Code: NAD
• UDI-Device Identifier: 10884389193938
• UDI-Public: 10884389193938
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: MSC2244EP
• Device Lot Number: R28725
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown