BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT)

    MDR report key: 8739022 · Received June 27, 2019

    Report

    Report Number
    2133409-2019-00006
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 25, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146C6S0
    PMA / PMN Number
    K153473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT HANDLING EVALUATION: DHR REVIEW WAS PERFORMED BY BRAEMAR MANUFACTURING, LLC QUALITY ASSURANCE, WITH NO CONTRIBUTING FACTORS IDENTIFIED. IFU PROVIDES WARNING INDICATIONS FOR DISCONTINUING USE AND CONTACTING A MEDICAL PRACTITIONER OR CUSTOMER SERVICE IN THE EVENT THAT SEVERE SKIN IRRITATION OCCURS. PATIENT INDICATED THAT THEY ARE ALLERGIC TO ADHESIVE AND CANNOT WEAR ANY DEVICES THAT HAVE ADHESIVES. MEDICAL AFFAIRS. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON 28-MAY-2019, BRAEMAR MANUFACTURING, LLC WAS MADE AWARE OF PATIENT ALLEGATION OF BURN/SKIN REACTION. THE PATIENT WORE A C6 PATCH MONITOR AND CONTACTED THEIR HEALTHCARE PROFESSIONAL DUE TO AN ALLEGATION OF BLISTERS AND SKIN IRRITATION. THE PATIENT INDICATED TO THEIR HEALTHCARE PROFESSIONAL THAT THE BURN/SKIN IRRITATION IS VERY SERIOUS AND THAT IT IS A THIRD DEGREE BURN. THE HEALTHCARE PROFESSIONAL CONTACTED THEIR ACCOUNT EXECUTIVE CONTACT AND NOTIFIED OF THE EVENT, INDICATING THAT THEY DO NOT BELIEVE THAT THE SKIN IRRITATION/BURN IS SERIOUS. NOTE: THE BECOME AWARE OF THE EVENT FOR LIFEWATCH SERVICES, INC. AND BRAEMAR MANUFACTURING IS 28-MAY-2019, BASED ON NOTIFICATION DATE BY THE INITIAL REPORTER LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533754 MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) MOBILE CARDIAC OUTPATIENT TELEMETRY PATCH SYSTEM (MCOT) DSI BRAEMAR MANUFACTURING, LLC 900-0634-00 B146C6S0

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other