BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCOT PATCH

    MDR report key: 9548408 · Received January 3, 2020

    Report

    Report Number
    2133409-2020-00001
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 6, 2019
    Report Date
    September 13, 2020
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146MCP0
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT (E.G., PICTURES) AND DEVICE RETURN FROM THE DISTRIBUTOR. ADDITIONAL FOLLOW-UP ATTEMPT(S) WERE MADE TO OBTAIN MORE INFORMATION REGARDING THE PATIENT. THE CUSTOMER/DISTRIBUTOR MADE OUTREACH ATTEMPTS TO THE PATIENTS (NO ADDITIONAL CONTACT COULD BE ESTABLISHED). 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 THIS RISK AND THE STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT (E.G., PICTURES) AND DEVICE RETURN FROM THE DISTRIBUTOR. ADDITIONAL FOLLOW-UP ATTEMPT(S) WERE MADE TO OBTAIN MORE INFORMATION REGARDING THE PATIENT. THE CUSTOMER/DISTRIBUTOR MADE OUTREACH ATTEMPTS TO THE PATIENTS (NO ADDITIONAL CONTACT COULD BE ESTABLISHED). 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 THIS RISK AND THE STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION SYMPTOMS FROM DEVICE USAGE. PATIENT REPORTED SEEKING MEDICAL ATTENTION/TREATMENT.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH SKIN IRRITATION SYMPTOMS FROM DEVICE USAGE. PATIENT REPORTED SEEKING MEDICAL ATTENTION/TREATMENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT (E.G., PICTURES) AND DEVICE RETURN FROM THE DISTRIBUTOR. ADDITIONAL FOLLOW-UP ATTEMPT(S) WILL BE MADE TO OBTAIN MORE INFORMATION FROM THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A SKIN BURN FROM DEVICE USAGE. PATIENT REPORTED SEEKING MEDICAL ATTENTION FOR STAPH INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5094 MCOT PATCH MCOT PATCH DSI BRAEMAR MANUFACTURING, LLC MCOT PATCH B146MCP0

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other