MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,ADHESVE,FABRIC,2"X4",ST,LF,50/BX

Catalog Number	NON25524
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the band aid only sticks to toe for about 1-2 minutes before falling off.".
Additional Manufacturer Narrative
The complaint was received related to weak adhesion from adhesive bandages; the customer reported the band aid was applied to the left big toe and only sticks for about 1-2 minutes before falling off.Neither physical samples nor photos of the reported issue were provided by the customer; the vendor was notified, trend analysis was performed, the vendor reviewed the production process, relevant records, and retained samples, and adhesive strength testing and the coa showed the product lot met specifications.Based on the information provided and the results of the investigation, medline was not able to confirm the reported issue or that the product failed to meet specifications.The cause was documented as sample required to determine cause, and no need for further action such as initiation of capas, scars and/or other risk management activities was indicated at this 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: CURAD
• Common Device Name: BANDAGE,ADHESVE,FABRIC,2"X4",ST,LF,50/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886616
• Report Number: 1417592-2026-50351
• Device Sequence Number: 9827165
• Product Code: KGX
• UDI-Device Identifier: 10080196325085
• UDI-Public: 10080196325085
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/23/2026

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: NON25524
• Device Lot Number: 90924080001
• 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: 10/08/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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