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

Catalog Number	MSCEX44EPH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Local Reaction (2035)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported, "general surgeon had 3 patients come back to her office with a reaction to the optifoam dressing that have had no prior allergies/reaction to adhesive" and "patients have an area of redness/reaction of where the dressing was placed." according to the customer contact "all 3 patients were given steroid to help with the reaction." it was reported, optifoam dressings "were used as dressing for umbilical hernia repairs." the customer contact stated, "patients had no co morbidities, no allergies, no creams or barriers were used." it was reported, "chloraprep was used to prep the patient with a 3-minute dry time before drapes we placed or procedure was started" preceding the reported incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
It was reported, "general surgeon had 3 patients come back to her office with a reaction to the optifoam dressing that have had no prior allergies/reaction to adhesive" and "patients have an area of redness/reaction of where the dressing was placed.".

• Brand Name: OPTIFOAM GENTLE EX
• Common Device Name: OPTIFOAM GENTLE EX, BORDERED, 4X4
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25735536
• Report Number: 1417592-2026-04583
• Device Sequence Number: 16090614
• Product Code: NAD
• UDI-Device Identifier: 10888277652637
• UDI-Public: 10888277652637
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 07/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MSCEX44EPH
• Device Lot Number: RX26125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown