BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ELECTRODE-PATCH

    MDR report key: 20055073 · Received August 23, 2024

    Report

    Report Number
    2133409-2024-00053
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146PE20
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A BURN THAT CAUSED RAW, VERY PAINFUL OPEN SORES ON THEIR CHEST UNDER THE UNIVERSAL PATCH. THE UNIVERSAL PATCH OR MCOT SENSOR WAS NOT RETURNED FOR DEVICE EVALUATION. ENGINEERING EVALUATION WAS UNABLE TO BE PERFORMED ON THE PATCH AS IT IS SINGLE USE AND WAS NOT RETURNED. ALLEGATION IS CONFIRMED THROUGH IMAGES OF PATIENT SKIN IRRITATION ATTACHED TO THIS CASE AND IS MOST PROBABLE TO BE A BIO-INCOMPATIBILITY ISSUE WITH THE ELECTRODE ADHESIVE AND/OR HYDROGEL COMPONENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS BURNED BY THE C6 SENSOR WHILE THEY WERE SLEEPING. THE PATIENT REPORTED THAT THE SENSOR ELECTROCUTED AND "SEVERELY" BURNED THEM. THE PATIENT REPORTED THAT THERE WAS A BURN ON THEIR CHEST IN THE SHAPE OF THE SENSOR. THE PATIENT DETAILED THAT THE BURN WAS PAINFUL, VERY RED AND OPEN SORE AND RAW. DUE TO THE BURN THE PATIENT WENT TO THE URGENT CARE. IT IS UNCLEAR IF THEY BURN WAS TREATED WITH ANY MEDICATION. THIS REPORT IS RELATED TO 133409-2024-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743412 UNIVERSAL ELECTRODE-PATCH ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL DSI BRAEMAR MANUFACTURING, LLC 02-01609 U602909 B146PE20

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention