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

Catalog Number	MDSM616201
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	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ekg electrodes "do not stick to the patient¿s chest and come off easily" and "in the middle of the test, the electrodes still come off.".
Additional Manufacturer Narrative
The customer reported that the ekg electrodes do not stick to the patient¿s chest and come off easily, and that the electrodes still come off in the middle of the test.Medline received 4 medgel resting tab electrodes in open condition; visual inspection did not reveal any manufacturing defects, and adhesive testing was performed by attaching the four samples to skin for two hours.The complaint was not confirmed, and no adhesive issues were experienced during testing.Based on the review of the details provided for the complaint investigation, 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, ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691503
• Report Number: 1417592-2026-34714
• Device Sequence Number: 17624082
• Product Code: DRX
• UDI-Device Identifier: 40888277352330
• UDI-Public: 40888277352330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/08/2026

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: MDSM616201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2024
• 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: 01/12/2024
• Initial Report FDA Received Date: 09/09/2026
• 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