MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,ADHESIVE,FABRIC,KNUCKLE,STRL,LF

Catalog Number	NON25510
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr summary report covers malfunction events that occurred in q2 of 2023.The report summarizes 2 malfunction events involving adhesive bandages (non25510).Customer reported that "was there any problems with your product adhering? they just won't stay on".The reported devices were associated with lot numbers 210401, and 210402.Associated di: (b)(4).
Additional Manufacturer Narrative
This vmsr summary report covers malfunction events that occurred in q2 of 2023.The report summarizes 2 malfunction events involving adhesive bandages (non25510).Customer reported that "was there any problems with your product adhering? they just won't stay on".The reported devices were associated with lot numbers 210401, and 210402.Associated di: (b)(4).Samples of non25510 were provided by the customer, and medline evaluated the samples and 6 months of complaint history for this item.From the samples provided, medline was unable to confirm the reported issue that the product had weak adhesion, and it could not be established that the root cause was directly related to the manufacture of the product.Medline had not had any similar complaints, and at this time this is not a trending issue; 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: BANDAGE,ADHESIVE,FABRIC,KNUCKLE,STRL,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50873636
• Report Number: 1417592-2026-49487
• Device Sequence Number: 21498117
• Product Code: KGX
• UDI-Device Identifier: 40080196740049
• UDI-Public: 40080196740049
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: NON25510
• Device Lot Number: 210401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2023
• 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: 06/27/2023
• Initial Report FDA Received Date: 09/23/2026
• 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