MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CURAD,BANDAGES,ASST,NO TRAY

Catalog Number	CURCC300NTH
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	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the entire box of bandages are just falling off within minutes" and "it feels as if there is barely any adhesive on them.".
Additional Manufacturer Narrative
The customer reported that the bandages were not staying on, there was barely any adhesive on them, and in follow-up correspondence stated they bunch up and "i get blustered on a new part of my heel." no photo or physical samples of the complaint item or complaint issue were provided by the customer for review, limiting the ability to investigate the issue thoroughly; analysis of complaint data was performed and identified two similar complaints, both unconfirmed and related to product lots from another lot.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 listed as unconfirmed, sample required to determine cause, and the investigation indicated no need for further action at this time; complaints will continue to be monitored for tracking and trending purposes.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: CURAD,BANDAGES,ASST,NO TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753250
• Report Number: 1417592-2026-39056
• Device Sequence Number: 9195223
• Product Code: KGX
• UDI-Device Identifier: 00888277420031
• UDI-Public: 00888277420031
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/14/2026

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: CURCC300NTH
• Device Lot Number: 240903
• 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: 03/10/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female