MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BNDG,ANTIBAC,,FNG/KNK,6-CLR,20CT

Catalog Number	CURIM5021V1
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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it appears that both sets of these have very little if any adhesive hold to them.I used numerous bandages from both boxes, often having to replace the bandage within 15 to 30 minutes.".
Additional Manufacturer Narrative
A complaint was received related to weak adhesion from adhesive bandages; the customer reported that both sets had very little if any adhesive hold and that numerous bandages often had to be replaced within 15 to 30 minutes.Neither physical samples nor photos of the reported issue were provided by the customer, the vendor was notified of the issue, and trend analysis was performed by reviewing the past two years of complaint data.The vendor¿s review of the production process, relevant records, and retained samples from the product lot noted that there were no indications of potential causes to the reported issue, and 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 complaints will continue to be monitored via the trend analysis procedure.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: BNDG,ANTIBAC,,FNG/KNK,6-CLR,20CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756395
• Report Number: 1417592-2026-39560
• Device Sequence Number: 9551019
• Product Code: FRO
• UDI-Device Identifier: 00193489023476
• UDI-Public: 00193489023476
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113583
• 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): 09/10/2026

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: CURIM5021V1
• Device Lot Number: 241201
• 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: 01/26/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown