MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIFOAM GENTLE EX, SACRUM, 9X9

Catalog Number	MSCEX99EP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Peeling (1999); Skin Inflammation/ Irritation (4545)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 9x9 sacral and heel dressing are too sticky and causing patients skin to peel off when removing.".
Additional Manufacturer Narrative
According to the facility, "when the dressing is removed on day 3 the dressings are extra sticky and removing patients¿ skin"; the dressing was applied on "very fragile skin" and when removed the skin was described as "red and inflamed." the received sample was evaluated, nothing abnormal was observed with the sample¿s adhesion, and the supplier tested adhesion and it met specifications for this product.The customer reported issue could not be confirmed with the received sample and additional answers given by the sales rep.The cause was documented as not confirmed with received sample, and the regulatory investigation concluded that this is not reportable with no adverse trending identified.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, SACRUM, 9X9
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855293
• Report Number: 1417592-2026-47680
• Device Sequence Number: 15941075
• Product Code: NAD
• UDI-Device Identifier: 30888277652662
• UDI-Public: 30888277652662
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/22/2026

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: MSCEX99EP
• Device Lot Number: RX17723
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2024
• 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: 04/09/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown