MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ELECTRODE,BLADE,2.75,SIL-SS

Catalog Number	SIL1456B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,BLADE,2.75,SIL-SS
• 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: 50696470
• Report Number: 1417592-2026-35160
• Device Sequence Number: 12235062
• Product Code: GEI
• UDI-Device Identifier: 20193489015932
• UDI-Public: 20193489015932
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182812
• 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): 09/04/2026

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: SIL1456B
• Device Lot Number: 2023051890
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2023
• 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: 12/15/2023
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (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