MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,FOAM,MONITORING,SLD GEL,5 PK

Catalog Number	MDSM611505
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Wheal(s) (2241)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "several patients have experience redness and welt formation where the electrodes were placed.Very often the redness is in the area of the surgical site.".
Additional Manufacturer Narrative
A complaint was received that medline foam monitoring electrodes caused red welts during use, with "redness and welts noted on the patient where the ecg electrodes were placed." medline received one pack of foam monitoring electrodes in new condition, forwarded the electrodes to the vendor for further investigation, and the vendor evaluated retained samples; electrodes were applied to intact, uncompromised skin of random in-house volunteers, and visual check and dhr review were performed.The complaint was not confirmed, and none of the volunteers complained about any skin trouble such as redness or welt formation; internal testing did not replicate the issue reported by the customer.Nothing significant to skin redness could be proven as root cause, the root cause remains inconclusive, the adhesive of the base material and the gel itself exhibited no signs of toxicity, irritation or sensitization, the product met qc release specifications, external control issues were not observed, and manufacturing batch record did not uncover any abnormalities.There were no reports of death, serious injury, medical intervention, or follow up care.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,FOAM,MONITORING,SLD GEL,5 PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883361
• Report Number: 1417592-2026-49817
• Device Sequence Number: 21521300
• Product Code: DRX
• UDI-Device Identifier: 40884389830339
• UDI-Public: 40884389830339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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: MDSM611505
• Device Lot Number: 65924030068
• 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: 10/16/2024
• Initial Report FDA Received Date: 09/24/2026
• 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