BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCT 3L: UNIVERSAL GATEWAY

    MDR report key: 13605828 · Received February 25, 2022

    Report

    Report Number
    3027765-2022-00003
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    February 21, 2022
    Report Date
    February 25, 2022
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT CONSULTED A CLINICIAN AND PRESENTED WITH A MILD ITCH, BROKEN SKIN AND BLISTERS. THE PHYSICIAN PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM TO APPLY TO THE AFFECTED AREA. THE PATIENT WAS PROVIDED WITH A DIFFERENT TYPE OF ELECTRODE TO CONTINUE ENROLLMENT. PER PATIENT USER GUIDE SUP546, PATIENTS ARE PROVIDED WARNING STATEMENTS REGARDING ELECTRODE SKIN IRRITATION. PATIENTS ARE INSTRUCTED TO CONTACT LIFEWATCH SERVICES CUSTOMER SUPPORT PRIOR TO USING THE MCT 3L MONITORING SYSTEM IF THEY HAVE KNOWN ALLERGIES TO NICKEL OR OTHER METALS. THE PATIENT IS ALSO INFORMED IN THE USER GUIDE THAT IF THEY DEVELOP SKIN IRRITATION THEY SHOULD CONTACT THEIR HEALTHCARE PROFESSIONAL. THE IFU LOCATED ON THE POUCH STATES THE ELECTRODES ARE HYPOALLERGENIC AND AN ELECTRODE IS TO BE WORN FOR LESS THAN 72 HOURS. THE ELECTRODES ARE ALSO PVC AND LATEX FREE. THE ELECTRODE SUPPLIER HAS NOT UNDERGONE CHANGES IN THE PRODUCTION PROCESS OR RAW MATERIALS AND MEET REQUIREMENTS FOR SKIN SENSITIVITY / CYTOTOXICITY / IRRITATION. NO ADDITIONAL INFORMATION IS KNOWN TO LIFEWATCH SERVICES, INC. AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL DUE TO BROKEN SKIN BLISTERS AND IRRITATION WHERE MEDICATION WAS PRESCRIBED (TRIAMCINOLONE ACETONIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436852 MCT 3L: UNIVERSAL GATEWAY SENSOR DSI LIFEWATCH SERVICES, INC. ACT 3-LEAD MCT 202110041

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other