MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE, ECG, FOAM, 3PK

Catalog Number	MDSM611503H
Medical Device Problem Codes	Signal Artifact/Noise (1036); Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that updated packaged sku is less durable, button connectors are coming apart from pad and they are not sticking and generating a lot of artifact when used.
Additional Manufacturer Narrative
The customer reported the updated packaged sku is less durable, button connectors are coming apart from pad, they are not sticking, and generating a lot of artifact when used.Through internal investigation, including dhr review and inspection records review, no abnormalities were found; electrodes from retained lot were checked for fitment issues, and none of the electrodes demonstrated failures or irregularities.A sample was not received for investigation, and the complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo.The cause was sample required to determine cause, and based on the review of the details provided, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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, FOAM, 3PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50950260
• Report Number: 1417592-2026-54802
• Device Sequence Number: 9552190
• Product Code: DRX
• UDI-Device Identifier: 10884389830321
• UDI-Public: 10884389830321
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K041954
• 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): 09/29/2026

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: MDSM611503H
• Device Lot Number: 10 65923110013
• 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: 08/30/2024
• Initial Report FDA Received Date: 09/30/2026
• 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