BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 SENSOR 3.0

    MDR report key: 25126671 · Received May 8, 2026

    Report

    Report Number
    2133409-2026-00086
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 11, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT EXPERIENCED A SKIN BURN ASSOCIATED WITH THE MCOT SENSOR 3.0. THE PATIENT ALSO REPORTED ON (B)(6) 2026, ALSO REPORTED SKIN BURNING FROM THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS, AS WELL AS FLUCTUATING FEVERS. PHILIPS AM&D IS CURRENTLY CONDUCTING AN INVESTIGATION INTO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT EXPERIENCED A SKIN BURN ASSOCIATED WITH THE MCOT SENSOR 3.0. THE PATIENT LATER REPORTED ON (B)(6) 2026, SKIN BURNING FROM THE ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS, AS WELL AS FLUCTUATING FEVERS. THE PATIENT WAS ADVISED TO SEEK EMERGENCY CARE IF SYMPTOMS WORSENED. DURING THE TIME OF THE EVENT, THE PATIENT WAS PERFORMING NORMAL DAILY ACTIVITIES AND STATED THAT THE DEVICE FELT HOTTER THAN NORMAL. THE PATIENT DENIED EXPOSURE OF THE SENSOR TO ELEVATED ENVIRONMENTAL TEMPERATURES. THE PATIENT WAS ADVISED THAT MONITORING COULD BE EXTENDED IF NEEDED, AND WAS INSTRUCTED TO VISIT URGENT CARE. THE PATIENT WAS ALSO OFFERED AN ALTERNATIVE WEAR OPTION USING THE FLEX DEVICE. HOWEVER, THE PATIENT OPTED FOR TEMPORARY BREAK IN SERVICE. ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED FROM THE PATIENT ON 21 APRIL 2026. THE PATIENT CONFIRMED THAT THE SENSOR FELT WARM TO THE TOUCH AND CLARIFIED THAT THE ADHESIVE CAUSED A CHEMICAL BURN CONSISTENT WITH THE SHAPE OF THE PATCH ADHESIVE. THE PATIENT REPORTED HAVING APPROXIMATELY 30 MINUTES OF SUN EXPOSURE TWO DAYS PRIOR TO EXPERIENCING THE SENSOR WARMING. THE PATIENT STATED THAT THE UNIVERSAL PATCH WAS NOT REPLACED AND THAT A PREVIOUSLY APPLIED PATCH WAS IN USE AT THE TIME OF THE BURN. THE PATIENT VISITED URGENT CARE AND IT WAS CONFIRMED A CHEMICAL BURN IN THE SHAPE OF THE PATCH ADHESIVES AND RECEIVED A SECOND-DEGREE BURN AT THE SENSOR SITE. THE PATIENT WAS PRESCRIBED BACTINE BURN OINTMENT AND ADVISED USING OTC TYLENOL AND IBUPROFEN FOR PAIN MANAGEMENT. THE MONITORING SERVICE WAS PAUSED AND WILL NOT RESUME SERVICE UNTIL (B)(6) 2026. THE PATIENT REMOVED THE UNIVERSAL PATCH AND SENSOR AND REPORTED NO VISIBLE CHANGES TO THE DEVICE. THE PATIENT CONFIRMED THAT PROPER SKIN PREPARATION WAS PERFORMED AND DENIED ANY PRIOR HISTORY OF SKIN SENSITIVITY OR ALLERGIES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31642 C6 SENSOR 3.0 MCOT SENSOR - 3.0 DSI BRAEMAR MANUFACTURING, LLC 02-01846

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL,02-01609