MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OPTIFOAM GENTLE SA AG, POST OP, 4X8

Catalog Number	MSC9748
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	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "does not adhere well.".
Additional Manufacturer Narrative
The customer reported issue of "does not adhere well" with item number msc9748 (optifoam gentle sa ag, post op, 4x8).The vendor investigation reviewed device history records, raw material and inspection/testing records, complaint database, design change, and performed adhesion to steel testing on vendor retain sample and the returned customer sample.Testing of retain and customer sample confirmed the adhesion properties of the product as expected for the product type and all the result met the product specification; therefore, the reported issue was not confirmed.A root cause was not able to be determined, and device history records including the component and the raw material used indicate that the product had been manufactured in line with internal and customer specification.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 SA AG, POST OP, 4X8
• 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: 50945879
• Report Number: 1417592-2026-54154
• Device Sequence Number: 15859143
• Product Code: FRO
• UDI-Device Identifier: 10888277415393
• UDI-Public: 10888277415393
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K033732
• 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: MSC9748
• Device Lot Number: WO58533
• 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: 02/25/2025
• 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