BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH

    MDR report key: 15478562 · Received September 24, 2022

    Report

    Report Number
    2133409-2022-00010
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    September 12, 2022
    Report Date
    September 23, 2022
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST PROBABLE CAUSE OF THE THE SKIN CONDITION WAS ATTRIBUTABLE TO PATIENT PRE-EXISTING CONDITION OF SENSITIVE SKIN. 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. PATCH IS UNAVAILABLE FOR EVALUATION. PATIENT WAS ADVISED BY CUSTOMER SUPPORT TO SWITCH TO USAGE OF THE LEAD WIRE ADAPTER TWICE PER DAY TO CONTINUE USAGE. PATIENT WAS ADVISED ON REQUIREMENT OF CHANGING AND ROTATING ELECTRODES AND TO USE WATER AND SOAP ON THE SKIN AREA. THE PATIENT'S PHYSICIAN INFORMED THE PATIENT TO USE A PRESCRIPTION CREAM THAT THE PATIENT ALREADY HAD FOR A PRIOR INFLAMMATORY SKIN CONDITION. NO ADDITIONAL PRESCRIPTION WAS WRITTEN.

    Description of Event or Problem · 0

    BIOTEL HEART CUSTOMER SUPPORT NOTIFIED BRAEMAR THAT THE PATIENT CALLED WITH SKIN IRRITATION AND SOME BLEEDING FROM THE PATCH AND THAT NO SKIN PREP DONE. HER DOCTORS OFFICE USED ANTIBACTERIAL GEL TO TREAT THE SKIN CONDITION. THE DOCTOR INFORMED THE PATIENT TO USE A PRESCRIPTION CREAM THE PATIENT ALREADY HAD FOR INFLAMMATION (BETAMETHASONE VALERATE 0.1%). NO ADDITIONAL PRESCRIPTION WAS WRITTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875491 C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH DSI BRAEMAR MANUFACTURING, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other