MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SILICONE FABRIC ADH BNDG 3/4X3

Catalog Number	NON75100
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i just opened one and the non-stick pad is black?".
Additional Manufacturer Narrative
The customer reported using silicone 3/4 x 3 bandages and stated the non-stick pad is black.Photo and physical samples were received by quality, and upon visual inspection, there appears to be a black piece of tape on the wound pad; the vendor checked retained samples, but no black tape was observed.After evaluating the received samples, the reported issue is confirmed, and the root cause was due to human error as the nonconforming product was not identified by manufacturing personnel and removed prior to being included in the finished product.The corrective action is to retrain staff and stress the importance of removing this from the line, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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: SILICONE FABRIC ADH BNDG 3/4X3
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joachim kamanda ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754390
• Report Number: 1417592-2026-39211
• Device Sequence Number: 9668050
• Product Code: NAC
• UDI-Device Identifier: 30888277677757
• UDI-Public: 30888277677757
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/09/2026

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: NON75100
• Device Lot Number: 10321100006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2024
• 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: 01/30/2024
• Initial Report FDA Received Date: 09/14/2026
• 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