MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING, GEL FIBER, OPTICELL AG+,4X5

Catalog Number	MSC9845EP
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product "tends to deteriorate when exposed to moisture, compromising its structural integrity," "leaves behind fibers and residue in the wound bed, which may interfere with healing and require additional cleaning," and "adheres to the wound bed, often causing discomfort or pain during dressing changes.".
Additional Manufacturer Narrative
The customer reported that the product tends to deteriorate when exposed to moisture, leaves behind fibers and residue in the wound bed, and adheres to the wound bed, often causing discomfort or pain during dressing changes.Medline initiated an investigation using the information provided; photo received: no, sample received.In the absence of a physical sample, medline was unable to confirm the presence of a defect during this investigation.No root cause was identified, and a review of the complaint information as well as the results of the investigation indicate 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: DRESSING, GEL FIBER, OPTICELL AG+,4X5
• 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: 50945498
• Report Number: 1417592-2026-54089
• Device Sequence Number: 16059616
• Product Code: FRO
• UDI-Device Identifier: 10884389717301
• UDI-Public: 10884389717301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100693
• 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): 09/28/2026

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: MSC9845EP
• 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: 12/08/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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