MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,ADHESIVE,CURAD,200CT.ASSTD

Catalog Number	CUR0800RBH
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bandages adhesive is too weak, these bandages do not stick.He also advised the gauze pad portion of the bandage is too small.
Additional Manufacturer Narrative
The customer reported that the bandages adhesive is too weak, these bandages do not stick, and the gauze pad portion of the bandage is too small.Medline's investigation noted that neither a sample nor photos of the reported issue were available; without a sample or photos, the ability to confirm the reported issue is limited, and analysis of complaint data over the past two years by all versions and defect type determined that there were four past complaints similar in nature, however, no product defects were confirmed.Based on the information provided, medline was not able to confirm the reported issue or that the product failed to meet specifications; the cause code was unconfirmed defect - sample required to determine cause.A review of the complaint information as well as the results of the investigation indicate no need for further action at this time, and complaints are 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: BANDAGE,ADHESIVE,CURAD,200CT.ASSTD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50775299
• Report Number: 1417592-2026-40830
• Device Sequence Number: 10422356
• Product Code: KGX
• UDI-Device Identifier: 00884389158756
• UDI-Public: 00884389158756
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/11/2026

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: CUR0800RBH
• 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: 11/17/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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