BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    MDR report key: 8945876 · Received August 29, 2019

    Report

    Report Number
    2133409-2019-00010
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 17, 2019
    Report Date
    August 12, 2020
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    00850725007033
    PMA / PMN Number
    K110499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (B)(4) 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 DESCRIBED THE EXPERIENCED SKIN IRRITATION AS "ITCHING, SWOLLEN, REDNESS RASH AND THROAT FELT LIKE IT WAS CLOSING." THE PATIENT INDICATED THAT THE IRRITATION PRIMARY LOCATION WAS BEYOND THE ELECTRODE AREA. SPECIFIC PATIENT INSTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. THE PATIENT INDICATED THAT THEY DO NOT HAVE SENSITIVE SKIN OR ALLERGIES. THE PATIENT CONSULTED A CLINICIAN (OBSERVATION/COUNSELING) AND WAS NOT PRESCRIBED MEDICATION FOR THE SYMPTOMS, THEREFORE NO MEDICAL TREATMENT IS DEEMED TO HAVE BEEN ADMINISTERED. THE PATIENT SELF-TREATED WITH OVER THE COUNTER (OTC) BENADRYL LOTION. THE PATIENT WAS ALSO OFFERED ALTERNATIVE ELECTRODES THAT ARE MORE SUITABLE FOR SENSITIVE SKIN. THE EVENT IS BEING REPORTED IN ALIGNMENT WITH PATIENT ALLEGATION OF "THROAT FELT LIKE IT WAS CLOSING". THE AFFECTED DEVICE WAS RETURNED TO (B)(4), INC. ON 08/20/2019 WITH NO DEVICE FACTORS IDENTIFIED. DEVICE HISTORY RECORD WAS REVIEWED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. ELECTRODE LOT # WAS NOT AVAILABLE BY THE PATIENT. 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 · 0

    ON (B)(6) 2019, PATIENT NOTIFIED (B)(4), INC. OF SKIN IRRITATION/REACTION. THE SYMPTOMS WERE DESCRIBED BY THE PATIENT AS "ITCHING, SWOLLEN, REDNESS RASH AND THROAT FELT LIKE IT WAS CLOSING." NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED ((B)(4)).

    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 DESCRIBED THE EXPERIENCED SKIN IRRITATION AS "ITCHING, SWOLLEN, REDNESS RASH AND THROAT FELT LIKE IT WAS CLOSING." THE PATIENT INDICATED THAT THE IRRITATION PRIMARY LOCATION WAS BEYOND THE ELECTRODE AREA. SPECIFIC PATIENT INSTRINSIC, EXTRINSIC, AND PREVENTABLE FACTORS ARE UNKNOWN. THE PATIENT INDICATED THAT THEY DO NOT HAVE SENSITIVE SKIN OR ALLERGIES. THE PATIENT CONSULTED A CLINICIAN (OBSERVATION/COUNSELING) AND WAS NOT PRESCRIBED MEDICATION FOR THE SYMPTOMS, THEREFORE NO MEDICAL TREATMENT IS DEEMED TO HAVE BEEN ADMINISTERED. THE PATIENT SELF-TREATED WITH OVER THE COUNTER (OTC) BENADRYL LOTION. THE PATIENT WAS ALSO OFFERED ALTERNATIVE ELECTRODES THAT ARE MORE SUITABLE FOR SENSITIVE SKIN. THE EVENT IS BEING REPORTED IN ALIGNMENT WITH PATIENT ALLEGATION OF "THROAT FELT LIKE IT WAS CLOSING". THE AFFECTED DEVICE WAS RETURNED TO LIFEWATCH SERVICES, INC. ON 08/20/2019. DEVICE HISTORY RECORD WAS REVIEWED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, PATIENT NOTIFIED LIFEWATCH SERVICES, INC. OF SKIN IRRITATION/REACTION. THE SYMPTOMS WERE DESCRIBED BY THE PATIENT AS "ITCHING, SWOLLEN, REDNESS RASH AND THROAT FELT LIKE IT WAS CLOSING." NOTE: BECOME AWARE DATE IS (B)(4) 2019, PER COMPLAINT CASE GENERATED (CAS - (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739515 LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR DSI BRAEMAR MANUFACTURING, LLC MCT 3L 00850725007033

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other