BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

    MDR report key: 11324839 · Received February 12, 2021

    Report

    Report Number
    3027765-2021-00003
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 13, 2021
    Report Date
    September 1, 2021
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    UDI-DI
    00850725007101
    PMA / PMN Number
    K143359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 PATIENT RECEIVED MEDICAL ATTENTION DUE TO A PSORIASIS FLARE-UP THAT ALLEGEDLY STARTED FOUR DAYS AFTER BASELINING. SHE RECEIVED A "SHOT FOR ITCHINESS" AT THE HOSPITAL AND NOW USING OTC NEOSPORIN. THE PATIENT SAID THAT PSORIASIS IS A PREVIOUSLY DIAGNOSED SKIN CONDITION. ALTERNATIVE ELECTRODES WERE OFFERED TO THE PATIENT TO CONTINUE MONITORING, BUT THE PATIENT DECLINED AND NO LONGER WEARING THE DEVICE. 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. NISSHA MEDICAL TECHNOLOGIES/GRAPHIC CONTROLS INVESTIGATED THE EVENT, INCLUDING A REVIEW OF THE LOT RECORD PAPERWORK, QUALITY PLANS, AND ASSOCIATED PROCESSES. THIS REVIEW FOUND NO NONCONFORMANCES OR ANOMALIES. A TREND REPORT SHOWED THAT THERE HAVE NOT BEEN ANY SIGNIFICANT INCREASES IN SKIN REACTION COMPLAINTS OVER THE PAST THREE YEARS. NISSHA MEDICAL TECHNOLOGIES/GRAPHIC CONTROLS HAS CONSIDERED THIS COMPLAINT CLOSED. 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 TREATMENT WAS PRESCRIBED.

    Additional Manufacturer Narrative · 1

    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 PATIENT RECEIVED MEDICAL ATTENTION DUE TO A PSORIASIS FLARE-UP THAT ALLEGEDLY STARTED FOUR DAYS AFTER BASELINING. SHE RECEIVED A "SHOT FOR ITCHINESS" AT THE HOSPITAL AND NOW USING OTC NEOSPORIN. THE PATIENT SAID THAT PSORIASIS IS A PREVIOUSLY DIAGNOSED SKIN CONDITION. ALTERNATIVE ELECTRODES WERE OFFERED TO THE PATIENT TO CONTINUE MONITORING, BUT THE PATIENT DECLINED AND NO LONGER WEARING THE DEVICE. 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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218451 LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY) LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY) DSI LIFEWATCH SERVICES, INC. MCT 3L 21420V13 00850725007101

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other