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

Catalog Number	MDSM611850RCT
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Tears (2516)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "since they started sending us the ones with red on the packaging (its been months), we've had two significant skin tears, several complaints about bruising or skin issues at the electrode site during post-procedure phone calls, and in recovery every day we have people who have residual gluey paper that doesn't come off with the electrode that has to be scrubbed off with alcohol and its very difficult to get off.".
Additional Manufacturer Narrative
The customer reported receiving medline electrode that tears skin, and the facility reported the electrodes cause "skin tears, bruising, gum left on patient skin"; the electrodes were on for approximately "1-2 hours".At this time, a sample was not received for investigation, and investigation included review of recent complaint trends/scar activity for the last three trend reports.The investigation results were not confirmed, as the complaint issue can only be confirmed by further investigating the sample or a provided photo.The cause was not determined because a sample was required to determine cause; no trends were identified for the specified material number and corresponding defect type, and the division 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,RL,FOAM,50PK
• 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: 50841719
• Report Number: 1417592-2026-46400
• Device Sequence Number: 21398351
• Product Code: DRX
• UDI-Device Identifier: 20884389830434
• UDI-Public: 20884389830434
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/18/2026

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: MDSM611850RCT
• 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: 04/30/2025
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown