MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,RL,FOAM,5PK

Catalog Number	MDSM611805R
Medical Device Problem Codes	Signal Artifact/Noise (1036); Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,RL,FOAM,5PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50832006
• Report Number: 1417592-2026-45765
• Device Sequence Number: 9957294
• Product Code: DRX
• UDI-Device Identifier: 80884389830429
• UDI-Public: 80884389830429
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: MDSM611805R
• Device Lot Number: 65925020061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2025
• 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: 10/31/2025
• Initial Report FDA Received Date: 09/19/2026
• 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