MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE, PLASTIC,CURAD,2"X4",10CT

Catalog Number	CUR47437RBH
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	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the adhesive stops working after 24 hours and no longer stick.".
Additional Manufacturer Narrative
The customer reported that the adhesive stops working after 24 hours and no longer stick; the bandage had been applied for 24 hours to the back of upper arm, and allergic reaction or skin irritation was reported as no.No sample was received; the lot number was received and assigned qa for lot review, and the labelling on this product indicates that the bandage should be changed daily or when wet.Without the sample to evaluate, medline was unable to confirm the complaint or identify a potential root cause for the reported issue; the cause code was updated to dc: traced to user - knowledge.The reported concern was 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: BANDAGE, PLASTIC,CURAD,2"X4",10CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50774665
• Report Number: 1417592-2026-40733
• Device Sequence Number: 15808675
• Product Code: KGX
• UDI-Device Identifier: 00080196303048
• UDI-Public: 00080196303048
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: CUR47437RBH
• Device Lot Number: 90923090001
• 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: 04/04/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown