MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HYDROCOLLOID, EXUDERM SATIN, 4X4

Catalog Number	MSC5444
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported an issue with hydrocolloid, exuderm satin, 4x4, specifically regarding the release liner sticking and leaving remnants.The supplier and quality team were notified, and a formal investigation was initiated and completed; the vendor conducted a comprehensive review of device history records (dhr) and batch records, in-process and final inspection results, manufacturing processes, raw material quality, equipment calibration and preventive maintenance, employee training records, and retain sample evaluation.The issue could not be confirmed, as no product sample was received for evaluation, and in the absence of a product sample and the requested additional information, medline was unable to confirm the reported issue or identify a potential root cause.Based on the investigation report, including batch record review, retain sample testing, and supporting documentation, no discrepancies were identified that would negatively impact product quality or performance; all inspection and test results were within acceptable limits, and product functionality was confirmed.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.
Event or Problem Description
It was reported that the release liner is sticking to the hydrocolloid and leaving remnants on the dressing.

• Brand Name: MEDLINE
• Common Device Name: HYDROCOLLOID, EXUDERM SATIN, 4X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854728
• Report Number: 1417592-2026-47567
• Device Sequence Number: 18516061
• Product Code: NAD
• UDI-Device Identifier: 10080196744121
• UDI-Public: 10080196744121
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/21/2026

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: MSC5444
• Device Lot Number: C2501031
• 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: 07/09/2025
• Initial Report FDA Received Date: 09/22/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown