MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,HEAVY DUTY,CURAD,3/4X4-3/4,20CT

Catalog Number	CUR01101RB
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	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "your bandage is not adhering very long.I wore one for an hour today and already loosening on my finger.If you even get it slightly wet, it will unravel.".
Additional Manufacturer Narrative
The customer reported the bandage was "not adhering very long," was "already loosening" after one hour on the finger, and "if you even get it slightly wet, it will unravel." the photos provided by the customer were reviewed, a coa for the product lot was requested from the vendor, and trend analysis was performed by reviewing the past two years of complaint data; photos showed the bandage placed on the customer¿s index finger and the bandage was seen to peel up on the ends and not fully adhere to itself.The coa met all technical requirements including adhesive strength, and based on the results of the investigation, medline was unable to confirm the reported issue or that the product failed to meet specifications.No root cause was identified; the complaint information and investigation results indicated 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,HEAVY DUTY,CURAD,3/4X4-3/4,20CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50786562
• Report Number: 1417592-2026-41873
• Device Sequence Number: 9442940
• Product Code: KGX
• UDI-Device Identifier: 00080196037752
• UDI-Public: 00080196037752
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: CUR01101RB
• Device Lot Number: 240501
• 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: 11/06/2024
• Initial Report FDA Received Date: 09/16/2026
• 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