MAUDE Adverse Event Report: COVIDIEN BIS; ELECTRODE, CUTANEOUS

Model Number	186-0106
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reporter that the patient used the sensor for approximately three hours and later developed bruising on the forehead.On postoperative day one, a 3 cm area of redness was noted on the left forehead without itching or pain.Shortly afterward, the patient reported redness and pain in the left frontal area.The attending physician initially prescribed lindelon vg, which was later changed to locoid.On day two, three raised, 3 cm lesions appeared on the forehead, still without itching.The patient reported that the rash persisted and that locoid seemed ineffective.A dermatology consult was arranged.Examination showed well-demarcated edematous erythema at three forehead sites and one on the left temple.Delayed pressure urticaria was suspected, and betaseremin combination tablets and nerizona universal ointment were prescribed.

• Brand Name: BIS
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24895537
• Report Number: 2936999-2026-00134
• Device Sequence Number: 16089466
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: (01)20884521134307(17)270202(10)0802251H(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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 Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0802251H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female