BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 11143062 · Received January 8, 2021

    Report

    Report Number
    3027765-2021-00001
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    November 26, 2020
    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
    GA, 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. SPECIFIC PATIENT INSTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. NO PREVIOUSLY KNOWN SKIN SENSITIVITIES OR ALLERGIES WERE REPORTED BY THE PATIENT. THE PATIENT ALLEGEDLY CONSULTED A CLINICIAN AND WAS PRESCRIBED PREDNISONE. THE PATIENT WAS ALSO OFFERED ALTERNATIVE ELECTRODES THAT ARE MORE SUITABLE FOR SENSITIVE SKIN. 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 (LIFEWATCH CUSTOMER COMPLAINT REFERENCE CAS - (B)(4)). THE PATIENT ALSO USED ALTERNATE CARDINAL HEALTH ELECTRODES DURING THE COURSE OF THE ENROLLMENT. THE SUPPLIER WAS NOTIFIED OF THE EVENT AND LIFEWATCH IS AWAITING SUPPLIER RESPONSE REGARDING THEIR EVALUATION. (LIFEWATCH CUSTOMER COMPLAINT REFERENCE CAS - (B)(4)) NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC 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. SPECIFIC PATIENT INTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. NO PREVIOUSLY KNOWN SKIN SENSITIVITIES OR ALLERGIES WERE REPORTED BY THE PATIENT. THE PATIENT ALLEGEDLY CONSULTED A CLINICIAN AND WAS PRESCRIBED PREDNISONE. THE PATIENT WAS ALSO OFFERED ALTERNATIVE ELECTRODES THAT ARE MORE SUITABLE FOR SENSITIVE SKIN. 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 BRAEMAR MANUFACTURING, LLC 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
    35277 LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY) LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY) DSI LIFEWATCH SERVICES, INC. MCT 3L 3971V13 00850725007101

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other