BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C6 MCOT PPM

    MDR report key: 18148189 · Received November 16, 2023

    Report

    Report Number
    2133409-2023-00072
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED DEVICE GOT HOT AND LEAVED BURNS ON THE PATIENT. THE DEVICE WAS RETURNED FOR INVESTIGATION. DEVICE WAS ABLE TO CHARGE, AND DEVICE INVESTIGATION FOUND THAT THE TEMPERATURE FOR THE DEVICE WAS WITHIN NORMAL LIMITS. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE ELECTRODE WAS NOT RETURNED. ALLEGATION IS CONFIRMED AS THE IMAGE OF PATIENT SKIN IRRITATION SHOWS AND ANY SKIN IRRITATION IS MOST PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER DAUGHTER COMPLAINED THE DEVICE WAS BURNING HER. UPON REMOVING THE DEVICE, THE MOTHER NOTICED BURN MARKS ON THE DEVICE CONNECTORS AND ALSO SMALL RED BLISTERS ON THE CHILD'S SKIN. SHE WAS UNSURE IF THERE WAS AN ALLERGIC REACTION OR IF THE SKIN APPEARANCE WAS FROM THE DEVICE ITSELF BECAUSE OF THE BURN MARKS ON THE CONNECTORS. THE MOTHER REPORTED THAT THE PATIENT RECEIVED MEDICAL TREATMENT AND WAS PRESCRIBED AN OINTMENT. PATIENT MOTHER ADVISED PATIENT TOOK A SHOWER EARLIER IN THE DAY THAT WAS THE PRIOR WATER EXPOSER BEFORE THE EVENT OCCURRED. THIS IS RELATED TO MFR 2133409-2023-00072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228538 C6 MCOT PPM C6 MCOT PPM DSI BRAEMAR MANUFACTURING, LLC 02-01846

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Required Intervention 02-01609, P202115.