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	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the plastic is removed the adhesive is sticking to the plastic instead of to the electrode.
Additional Manufacturer Narrative
The customer stated that the adhesive is sticking to the plastic when they attempt to peel it off.We received 1pk, (b)(6) medgel resting tab electrodes in opened condition; samples were visually and functionally tested, and upon visual inspection, there was excess adhesive between the electrodes and almost appeared to have melted.The complaint was confirmed; during functional testing, the adhesive stuck to the plastic, which left the electrodes with no adhesive on them, making them unusable.The exact root cause remained inconclusive, and the issue reported may be caused by temperature variations in storage and delivery; division and vendor have been informed and will continue to monitor trends.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: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50840767
• Report Number: 1417592-2026-46203
• Device Sequence Number: 9957563
• Product Code: DRX
• UDI-Device Identifier: 30888277352326
• UDI-Public: 30888277352326
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/18/2026

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: 8592208004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2024
• 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: 03/19/2024
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (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