MAUDE Adverse Event Report: Medline Industries, LP Optifoam Gentle EX Bordered Foam Dressing; OPTIFOAM GENTLE EX, BORDERED, 4X4

Catalog Number	MSCEX44EP
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Optifoam Gentle EX Bordered Foam Dressing
• Common Device Name: OPTIFOAM GENTLE EX, BORDERED, 4X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50457667
• Report Number: 1417592-2026-09265
• Device Sequence Number: 10197601
• Product Code: NAD
• UDI-Device Identifier: 10888277652637
• UDI-Public: 10888277652637
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/26/2026

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MSCEX44EP
• Device Lot Number: RX35725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/26/2026
• 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 Age: 80 YR
• Patient Sex: Female