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

Catalog Number	NON75100Z
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bandages in the last box i brought stuck to my skin like they were regular bandages and definitely were not ouchless.".
Additional Manufacturer Narrative
The customer reported they have used curad¿s ouchless silicone bandages for years due to thin skin, but the bandages in the last box stuck to their skin like regular bandages and were not ouchless.No photo or physical samples of the complaint issue were received, limiting the ability to investigate the issue thoroughly; biocompatibility testing has been performed on all bandages, adhesive levels are monitored throughout the manufacturing process, every lot is tested for adhesive strength and weight, and trending over the past two years determined there were no other complaints with this product regarding the adhesive being too strong.Based on the results of the investigation, medline was unable to confirm the reported issue or that the product failed to meet specifications.The cause was documented as an unconfirmed defect, sample required to determine cause, and there was no need for further action at that time.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: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853740
• Report Number: 1417592-2026-47382
• Device Sequence Number: 10053621
• Product Code: NAC
• UDI-Device Identifier: 10888277677753
• UDI-Public: 10888277677753
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: NON75100Z
• Device Lot Number: 10323110002
• 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: 01/31/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown