MAUDE Adverse Event Report: Medline Industries, LP - Mexicali (MXC) MEDLINE; ELECTRODE,BLADE,2.75,SILICONE, INSULATED

Catalog Number	SIL1455
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: ELECTRODE,BLADE,2.75,SILICONE, INSULATED
• Manufacturer (Section D): Medline Industries, LP - Mexicali (MXC); c. cto del derierto 71; parque industrial del desierto; mexicali, baja california 21383 ; MX 21383
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50863073
• Report Number: 3015173212-2026-00025
• Device Sequence Number: 10661261
• Product Code: GEI
• UDI-Device Identifier: 10193489015898
• UDI-Public: 10193489015898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/22/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SIL1455
• Device Lot Number: 2026052790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown