BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 MCOT PPM

    MDR report key: 17718911 · Received September 11, 2023

    Report

    Report Number
    2133409-2023-00049
    Event Type
    Injury
    Date Received
    September 11, 2023
    Report Date
    February 7, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146PE20
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A FIRST DEGREE BURN UNDER THE UNIVERSAL PATCH. THE UNIVERSAL PATCH WAS NOT RETURNED FOR INVESTIGATION. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE ELECTRODE/DEVICE WAS NOT RETURNED. ALLEGATION IS CONFIRMED THROUGH THE NEED FOR A PRESCRIPTION AND 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

    THIS REPORT IS RELATED TO REPORT NUMBER 2133409-2023-00050.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT THEY WENT TO URGENT CARE FOR FIRST DEGREE BURNS UNDER THE PATCH. THE PATIENT WAS PRESCRIBED OINTMENT AND SWITCHED TO FLEX ADAPTOR AND CONTINUED WITH SERVICE. AFTER SWITHCING TO FLEX THE PATIENT RETURNED TO URGENT CARE AND RECEIVED MORE OINTMENT DUE TO FIRST DEGREE BURNS. THE PATIENT RETURNED THE KIT AND DID NOT FINISH SERVICE. THE PATIENT DOES HAVE A HISTORY OF SKIN SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143180 C6 MCOT PPM C6 MCOT PPM DSI BRAEMAR MANUFACTURING, LLC 02-01609 B146PE20

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention ELECTRODE - S&W, 470-0021-01