MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BANDAGE,PLASTIC,CURAD,3/4"X3"

Catalog Number	CUR02278
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	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "none of them stay stuck.They fall off in minutes like there is no glue.".
Additional Manufacturer Narrative
The customer reported trying 5 bandages that experienced weak adhesion.The physical sample was provided showing what appears to be an older artwork on the labelling; review found that the artwork was approved in 2014, the product was discontinued at the end of 2015, and the product appears to have been manufactured in 2011, which is beyond typical shelf life of adhesive bandages.The reported concern was not confirmed as a quality issue, and the cause code was updated to dc:traced to user - knowledge.This is not a quality issue, and there has been no change to the reportability decision associated with this complaint.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: DBD-BANDAGE,PLASTIC,CURAD,3/4"X3"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50732954
• Report Number: 1417592-2026-36880
• Device Sequence Number: 10569072
• Product Code: KGX
• UDI-Device Identifier: 00080196302829
• UDI-Public: 00080196302829
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/09/2026

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: CUR02278
• Device Lot Number: 19A11
• 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: 05/07/2024
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (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