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

Catalog Number	MDSM616201Z
Medical Device Problem Codes	Mechanical Problem (1384); Device Emits Odor (1425)
Health Effect - Clinical Codes	Local Reaction (2035); Skin Burning Sensation (4540)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "strong chemical smell and allergic reaction to patients skin also does not stick well.".
Additional Manufacturer Narrative
The facility reported the ecg electrodes had a ¿not normal chemical smell¿ when the package was opened, the smell was noticed by the adhesive portion, and the device would leave ¿minor redness on the skin after being applied and a burning sensation after being removed that would resolve within 5 minutes¿ without medical treatment or intervention; the complaint also stated the product ¿does not stick well.¿ medline received 3pk in new condition, opened two packs of electrodes to visually and functionally inspect them, and no abnormalities were noted in regards to the adhesion strength, texture, odor, and appearance of the electrodes reviewed; the vendor checked retained product and noticed nothing unusual with regard to the smell.The complaint was not confirmed, and the samples received worked as intended.No root cause was identified; the vendor stated that correlation with chemical / product smell could not be established, and medline concluded the complaint was not confirmed.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, A
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947304
• Report Number: 1417592-2026-54429
• Device Sequence Number: 16065178
• Product Code: DRX
• UDI-Device Identifier: 30888277352333
• UDI-Public: 30888277352333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/29/2026

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: MDSM616201Z
• Device Lot Number: 85921100004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2023
• 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: 01/27/2023
• Initial Report FDA Received Date: 09/30/2026
• 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