MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,ECG,STRESS,FOAM,50PK

Catalog Number	MDSM611950
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the issue was "inaccurate readings and spikes.".
Additional Manufacturer Narrative
The customer/reporter described the issue as "inaccurate readings and spikes." a sample(s) was not received for investigation; investigation included review of the lot/serial number and recent complaint trends/scar activity for the past 12 months, and through internal investigation including dhr review and inspection records review, no abnormalities were found.Per vendor, electrodes from retained lots were tested for electrical performance as per ansi/aami ec 12:2000 parametric requirements, all values were well within tolerances, no deviations were found, and products have performed as intended.The complaint could not be confirmed, and root cause has been found to be inconclusive as the claim could not be simulated.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,STRESS,FOAM,50PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50761421
• Report Number: 1417592-2026-39849
• Device Sequence Number: 9224705
• Product Code: DRX
• UDI-Device Identifier: 40884389830469
• UDI-Public: 40884389830469
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/10/2026

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: MDSM611950
• Device Lot Number: 10)65924010028
• 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: 09/30/2024
• Initial Report FDA Received Date: 09/14/2026
• 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