MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,ECG,STRESS,FOAM,5PK

Catalog Number	MDSM611905Z
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	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "lots of noise, troubles sticking, and inconsistent reads.".
Additional Manufacturer Narrative
The customer reported issues with stick-on ekg leads, including ¿lots of noise, troubles sticking, and inconsistent reads.¿ complaint samples were checked for electrical performance test as per ansi/aami ec 12:2000, and no problem with signals was observed and values were within the controlled specifications; device history records and inspection/testing records were reviewed and found in compliance with specifications, and user test found the samples applied on dry skin didn¿t come off or detach from the skin.The complaint is not confirmed.No root cause was identified, and no trends were identified for the specified material number and corresponding defect type.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: ELECTRODE,ECG,STRESS,FOAM,5PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754162
• Report Number: 1417592-2026-39175
• Device Sequence Number: 21249773
• Product Code: DRX
• UDI-Device Identifier: 50884389830459
• UDI-Public: 50884389830459
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: MDSM611905Z
• Device Lot Number: 65924110051
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2026
• 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: 03/20/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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