MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DRESSING,EXUDERM,LP/THIN,HDROCOLD,4X4

Catalog Number	MSC5100
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wound dressing is not as strong or holding as well as previous versions they have received.Customer states that the previous versions were sturdier and stuck to skin better.
Additional Manufacturer Narrative
Medline received a complaint regarding not as strong/holding as well; the customer reported the wound dressing was not as strong or holding as well as previous versions, and the product packaging included a handwritten note stating: "they are too thin ¿ hard to stick." the account returned a physical sample, and the product inside was new, unopened, and in its original packaging; the dressing appeared intact and unused, with no visible signs of contamination, damage, or manufacturing defects.Upon testing the returned sample, the adhesive performed as expected and held well, no issues were observed during evaluation, and the vendor review and peel strength testing results were qualified and met established product standards.Medline was unable to confirm the reported issue, the root cause has not been identified, and the product¿s performance complies with standard requirements.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,EXUDERM,LP/THIN,HDROCOLD,4X4
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868212
• Report Number: 1417592-2026-48698
• Device Sequence Number: 21501375
• Product Code: NAD
• UDI-Device Identifier: 10080196738526
• UDI-Public: 10080196738526
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: MSC5100
• Device Lot Number: 87525050022
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2025
• 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: 09/15/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown