BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCT 3L: UNIVERSAL GATEWAY

    MDR report key: 13194325 · Received January 7, 2022

    Report

    Report Number
    3027765-2022-00001
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 17, 2021
    Report Date
    January 7, 2022
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT CONSULTED A CLINICIAN AND PRESENTED WITH A MILD ITCH, RED AGGRAVATED CIRCLES AND PIMPLES WHERE THE ELECTRODES WERE LOCATED ON SKIN. THE PHYSICIAN PRESCRIBED A TOPICAL ANTIFUNGAL 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.

    Additional Manufacturer Narrative · 0

    THE PATIENT CONSULTED A CLINICIAN AND PRESENTED WITH A MILD ITCH, RED AGGRAVATED CIRCLES AND PIMPLES WHERE THE ELECTRODES WERE LOCATED ON SKIN. THE PHYSICIAN PRESCRIBED A TOPICAL ANTIFUNGAL 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 ALLERGIC REACTION/SKIN IRRITATION WHERE MEDICATION WAS PRESCRIBED.

    Description of Event or Problem · 0

    PATIENT COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL DUE TO ALLERGIC REACTION/SKIN IRRITATION WHERE MEDICATION WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155252 MCT 3L: UNIVERSAL GATEWAY SENSOR DSI LIFEWATCH SERVICES, INC. ACT 3-LEAD MCT 49220V13

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other