BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 MCOT UNIVERSAL PATCH

    MDR report key: 16401162 · Received February 17, 2023

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    Report

    Report Number
    2133409-2023-00004
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146PE20
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED OPEN, WET, AND BLEEDING BLISTERS. SKIN WAS PREPPED BY WASHING WITH WARM WATER, SOAP AND DRIED. PATIENT WENT TO ER, CORTISONE CREAM APPLIED. PATIENT WORE MONITOR FOR 5 DAYS AND HAD TO REMOVE DUE TO THE SKIN IRRITATION. PATIENT RETURNED THE MONITOR, BUT DID NOT RETURN THE PATCH WHICH IS WHAT CAUSED THE SKIN ISSUE. PATIENT DISCONTINUED SERVICE. 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

    PATIENT REPORTED OPEN, WET, AND BLEEDING BLISTERS. SKIN WAS PREPPED BY WASHING WITH WARM WATER, SOAP AND DRIED. PATIENT WENT TO ER, CORTISONE CREAM APPLIED. PATIENT WORE MONITOR FOR 5 DAYS AND HAD TO REMOVE DUE TO THE SKIN IRRITATION. PATIENT RETURNED THE MONITOR, BUT DID NOT RETURN THE PATCH WHICH IS WHAT CAUSED THE SKIN ISSUE. PATIENT DISCONTINUED SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557234 C6 MCOT UNIVERSAL PATCH C^MCOT UNIVERSAL PATCH DSI BRAEMAR MANUFACTURING, LLC 02-01609 P201496 B146PE20

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Other