MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,REPOSITIONABLE,MEDGEL

Catalog Number	MDSM611300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clinical staff have stated that they fall off on all patients regardless of how they apply them.
Additional Manufacturer Narrative
The reported issue was "not sticking," and clinical staff stated that the electrodes fall off on all patients regardless of how they apply them, citing poor quality which causes poor results and increased testing.Medline received 1pk of the medgel repositionable electrode in new condition, performed visual and functional inspection, and visual inspection revealed no abnormalities in regards to the texture, odor, and appearance of the electrodes; functional testing with a control pack showed similar adhesion strength and stickiness ability after an hour.The complaint was not confirmed, and the samples worked as intended.Based on the review of the details provided for the complaint investigation, 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,REPOSITIONABLE,MEDGEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771209
• Report Number: 1417592-2026-40291
• Device Sequence Number: 15882154
• Product Code: DRX
• UDI-Device Identifier: 40888277399380
• UDI-Public: 40888277399380
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: MDSM611300
• Device Lot Number: 65923110033
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2024
• 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: 10/11/2024
• Initial Report FDA Received Date: 09/15/2026
• 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