BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 MCOT PPM

    MDR report key: 18148155 · Received November 16, 2023

    Report

    Report Number
    2133409-2023-00071
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    July 15, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K081444
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT GOT BLISTERS AND A POSSIBLE ALLERGIC REACTION. THE SENSOR WAS RETURNED FOR INVESTIGATION. THE SENSOR WAS INVESTIGATED. 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. MARSI, SKIN BURN, AND ASSOCIATED SYMPTOMS MAY INHERENTLY OCCUR UNDER THE COURSE OF ECG MONITORING. NO SINGLE FACTOR OR COMBINATION OF FACTORS CAN BE ATTRIBUTABLE TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PRODUCT LABELING ADVISES PATIENTS OF ALTERNATE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY**

    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. THE MOTHER ALSO EXPRESSED CONCERN THAT THE INJURY WAS NOT BEING TAKEN SERIOUSLY. SUBSEQUENTLY, ADDITIONAL FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PATENT'S MOTHER STATING THAT OINTMENT WAS NOT PRESCRIBED, BUT RATHER AN OINTMENT WAS APPLIED TO SKIN BY A SCHOOL NURSE. SHE DIDN'T KNOW WHAT OINTMENT WAS APPLIED. THE MOTHER ALSO STATED THAT THE PATIENT DID NOT HAVE A KNOWN PRIOR SKIN SENSITIVITY. ALCOHOL WIPES WERE USED PRIOR TO APPLYING THE PATCH. THIS IS RELATED TO MFR 2133409-2023-00072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240169 C6 MCOT PPM C6 MCOT PPM DSI BRAEMAR MANUFACTURING, LLC 02-01609 02-01609

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female UNIT, C6S 3.0, BTH, 02-01846