BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT

    MDR report key: 17105280 · Received June 12, 2023

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    Report

    Report Number
    2133409-2023-00027
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 18, 2023
    Report Date
    October 3, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146C6E10
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED AS THE ELECTRODE/DEVICE WAS NOT RETURNED. ALLEGATION IS CONFIRMED THROUGH DESCRIPTION OF THE SKIN IRRITATION AND IS MOST PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVE. THE PATIENT HAD PREEXISTING SKIN SENSITIVITIES. 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

    CORRECTION: D4

    Description of Event or Problem · 0

    PATIENT REPORTED THAT WAS SENSOR BATTERY WAS ONLY LASTING 2 DAYS AND WAS NOT GIVEN A REPLACEMENT FROM AGENT. AFTER A FEW MORE DAYS THE SENSOR GOT HOT AND BURNED HER. SHE SAID SHE HAD BLISTERS UNDER THE SENSOR AND ELECTRODES IN THE PATCH. SHE HAD TO TAKE THE DEVICE OFF. THE PATIENT WAS ADVISED TO TAKE THE DEVICE OFF AND A REPLACEMENT DEVICE WAS ORDERED AND PATIENT WILL SWITCH TO LWA (LEAD WIRE ADAPTER). ADDITIONAL INFORMATION WAS OBTAINED ON 31 MAY 2023 FROM PATIENT SERVICES AND THE PATIENT: THE PATIENT REPORTED THAT SHE WAS EXPERIENCING PAIN FROM THE AREA WHERE THE PATCH WAS "BLISTERS UNDER THE PATCH" AND "SENSOR GETTING HOT AFTER CHARGING," THE BLISTERS ARE LIKE CIGARETTE BURNS. THE PATIENT STATED THAT SHE WILL BE SEEING HER FAMILY DOCTOR. THE PATIENT ALSO STATED THAT SHE HAS PRE EXISTING SKIN SENSITIVITIES. THE PATIENT WAS PRESCRIBED BURN OINTMENT AND ANTIBIOTIC STEROIDS CREAM FOR SECOND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276958 UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT UNIT C6S, 3.0 BTH/ELCTRD, PATCH, UNIV 2CH, BOX, 40CT DSI BRAEMAR MANUFACTURING, LLC 02-01846 B146C6E10 B146C6E10

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other