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

Catalog Number	MSC5444
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	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it is not sticking as well in past.
Additional Manufacturer Narrative
The customer reported issue with hydrocolloid, exuderm satin, 4x4 regarding "not sticking well".Vendor/manufacturer reviewed any potential cause of defect of dhr and batch record, inspection record, manufacturing, raw material and equipment calibration and preventive maintenance, employee training, and retain sample; all met the specification as required.The vendor reviewed the temperature, humidity, and pressure for the cleanroom, no issues were observed, and 10 samples from euromed retains were tested with results within specifications limits.After conducting the investigation, the issue reported in the complaint regarding the "not sticking well" could not be confirmed with the received sample for investigation; at this time medline cannot confirm based off the information received, and the division will continue to monitor trending through the quarterly trend reports.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: HYDROCOLLOID, EXUDERM SATIN, 4X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869685
• Report Number: 1417592-2026-48924
• Device Sequence Number: 13440558
• Product Code: NAD
• UDI-Device Identifier: 10080196744121
• UDI-Public: 10080196744121
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: MSC5444
• Device Lot Number: C2410281
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2025
• 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: 04/04/2025
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown