MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,ECG,TAB,10/CARD,5000/CS, S

Catalog Number	MDSM616101Z
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	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pads do not stick properly.
Additional Manufacturer Narrative
The customer reported receiving medline medgel resting tab electrodes that were not sticking during use.Medline received returned electrodes in new condition, randomly selected 25 samples and performed visual and functional inspection; the visual inspection revealed no abnormalities in regard to the texture, odor, and appearance, and functional testing showed adequate adhesion strength and stickiness ability after an hour wearing them.The complaint was not confirmed.From the available device history records, machine logbooks, and quality control reports, no substantial issues were found during manufacturing stages, there were no changes made in the raw materials/raw material suppliers and/or production process flow, and the root cause of reported problem remains inconclusive; based on the review, 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,TAB,10/CARD,5000/CS, S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50857008
• Report Number: 1417592-2026-47976
• Device Sequence Number: 21209335
• Product Code: DRX
• UDI-Device Identifier: 30888277352326
• UDI-Public: 30888277352326
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093327
• 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): 09/22/2026

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: MDSM616101Z
• Device Lot Number: 85924020002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/14/2025
• 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: 12/18/2024
• Initial Report FDA Received Date: 09/22/2026
• 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