MAUDE Adverse Event Report: Medline Industries, LP Centurion; DRESSING, SURESITE SELECT, 2.75"X2 7/8"

Catalog Number	VAD1683
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	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suresite dressing vad1683 is not adhering properly.
Additional Manufacturer Narrative
The account reported complaints that the suresite dressing vad1683 was not adhering properly and that it had peeled off of patients.A sample was received for investigation; 3 ea were received and 20 ea were pulled from inventory, and the samples returned and the samples from inventory had visual presence of the adhesive and passed functional testing by application and removal from a test surface.No defects were identified, and medline was unable to confirm the reported issue.At this time, the root cause cannot be determined for this issue, and this issue will be monitored by centurions complaint system.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: Centurion
• Common Device Name: DRESSING, SURESITE SELECT, 2.75"X2 7/8"
• Manufacturer (Section D): Medline Industries, LP; 301 catrell drive; howell MI 48843
• Manufacturer Contact: urmi parekh ; 301 catrell drive; howell, MI 48843
• MDR Report Key: 50804237
• Report Number: 1824619-2026-00070
• Device Sequence Number: 21057954
• Product Code: KMK
• UDI-Device Identifier: 00653160329018
• UDI-Public: 00653160329018
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/17/2026

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: VAD1683
• Device Lot Number: 2023071701
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2023
• 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: 09/08/2023
• Initial Report FDA Received Date: 09/17/2026
• 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