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

Catalog Number	MDSM611503
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a post op/follow up after a colonoscopy and had irritation on the skin where the ecg was replaced; skin reaction.
Additional Manufacturer Narrative
It was reported that the patient had a post op/follow up after a colonoscopy and had irritation on the skin where the ecg was replaced; skin reaction.The patient did not report any known allergies prior to the procedure.A sample was not received for investigation; investigation included review of recent complaint trends for the past 12 months, and the vendor evaluated retained samples, device history records, machine logbooks, and qc reports.The complaint was not confirmed; nothing significant to skin irritation could be proven as root cause of the reported claim, and the root cause remains inconclusive.The adhesive of the base material and the gel itself exhibited no signs of cytotoxicity, skin irritation or skin sensitization, and 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: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855331
• Report Number: 1417592-2026-47694
• Device Sequence Number: 10025913
• Product Code: DRX
• UDI-Device Identifier: 40884389830322
• UDI-Public: 40884389830322
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/22/2026

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: MDSM611503
• Device Lot Number: 65923070004
• Was Device Available for Evaluation?: No
• 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: 11/13/2024
• Initial Report FDA Received Date: 09/22/2026
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Weight: 178 LB