BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

    MDR report key: 9820058 · Received March 11, 2020

    Report

    Report Number
    3027765-2020-00002
    Event Type
    Injury
    Date Received
    March 11, 2020
    Date of Event
    January 31, 2020
    Report Date
    January 10, 2021
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    UDI-DI
    00850725007033
    PMA / PMN Number
    K110499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A 64-YEAR-OLD FEMALE PATIENT WORE THE DEVICE FOR APPROXIMATELY SEVEN (7) DAYS AND SAID THAT SHE STARTED EXPERIENCING AN "ALLERGIC REACTION" FROM THE ELECTRODES WITHIN THE FIRST 12 HOURS AFTER SHE STARTED WEARING THE DEVICE. THE PATIENT INDICATED THAT SHE WENT TO THE ER TO SEEK MEDICAL ATTENTION, SHE WAS PRESCRIBED STEROID CREAM WHICH SHE DID NOT GET FILLED. INSTEAD, THE PATIENT SELF-TREATED WITH CORTISONE SHE ALREADY HAD AVAILABLE AT HOME. THE PATIENT SAID THAT SHE IS "HIGHLY ALLERGIC TO LATEX".. ELECTRODE SUPPLIER EVALUATED THE CUSTOMER COMPLAINT, INCLUDING A REVIEW OF THE LOT RECORD PAPERWORK, QUALITY PLANS, AND ASSOCIATED PROCESSES. THIS REVIEW FOUND NO NONCONFORMANCES OR ANOMALIES. THERE WERE NO CHANGES IN THE PRODUCTION PROCESS OR THE RAW MATERIALS. THE BIOCOMPATIBILITY RECORDS OF BOTH THE ADHESIVE SUBSTRATE AND THE GEL WERE REVIEWED AND FOUND TO MEET ALL THE REQUIREMENTS FOR SKIN SENSITIVITY/CYTOTOXICITY/IRRITATION. THE IFU LOCATED ON THE POUCH STATES THE ELECTRODES ARE HYPOALLERGENIC AND AN ELECTRODE IS ONLY TO BE WORN FOR LESS THAN 72 HOURS. THE ELECTRODES ARE ALSO PVC AND LATEX FREE. THE PATIENT'S PRE-DISPOSITION TO SKIN REACTIONS IS MOST LIKELY A CONTRIBUTING FACTOR IN THE EVENT. THE PATIENT SHOWED A NOTICEABLE REACTION WITHIN 12 HOURS BUT CONTINUED TO USE THE PRODUCT FOR A TOTAL OF SEVEN DAYS. THE MCT-3L IFU (SUP546) CONTAINS WARNING INDICATIONS REGARDING SKIN IRRITATION. THE IFU ALSO WARNS THAT IF IRRITATION WORSENS OR BECOMES SEVERE, CONTACT LIFEWATCH TO OBTAIN AN ALTERNATIVE TYPE OF ELECTRODE. IF THERE ARE QUESTIONS REGARDING TREATING IRRITATED SKIN, PLEASE CONTACT YOUR PRESCRIBING PHYSICIAN OR HEALTH OR CARE PROFESSIONAL. NO ADDITIONAL INFORMATION IS KNOWN TO LIFEWATCH SERVICES, INC.

    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

    A DHR REVIEW WAS PERFORMED, WITH NO CONTRIBUTING FACTORS IDENTIFIED. THE AFFECTED DEVICE HAS NOT BEEN RECEIVED BY LIFEWATCH SERVICES, INC. THE PATIENT REPORTED SENSITIVE SKIN / ALLERGY AND BEING HIGHLY ALLERGIC TO LATEX. THE PATIENT WENT TO THE ER DUE TO SKIN IRRITATION WHICH SHE BELIEVES IS A SKIN REACTION DUE TO THE ELECTRODE SHE WAS USING. A STEROID CREAM WAS PRESCRIBED TO THE PATIENT BUT SHE DID NOT GET THE PRESCRIPTION FILLED. INSTEAD THE PATIENT SELF-TREATED WITH CORTISONE CREAM SHE ALREADY HAD AT HOME. SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. THE MCT-3L USER GUIDE (SUP546 REV. G) INCLUDES WARNING STATEMENTS STATING THE FOLLOWING: MINOR SKIN IRRITATION CAN OCCUR WITH ELECTRODE USE. CAREFULLY, FOLLOW THE INSTRUCTIONS IN THIS SECTION. IF SKIN IRRITATION OCCURS, DO NOT PLACE THE ELECTRODES IN THE SAME LOCATION AS THE IRRITATED SKIN. INSTEAD, APPLY THE REPLACEMENT ELECTRODES ADJACENT TO THE ORIGINAL SITES TO CONTINUE AN ACCURATE READING. IF IRRITATION WORSENS OR BECOMES SEVERE, CONTACT LIFEWATCH TO OBTAIN AN ALTERNATIVE TYPE OF ELECTRODE. IF THERE ARE QUESTIONS REGARDING TREATING IRRITATING SKIN, PLEASE CONTACT YOUR PRESCRIBING PHYSICIAN OR HEALTH CARE PROFESSIONAL. ALTERNATIVE ELECTRODES ARE AVAILABLE FOR PATIENTS WITH A HISTORY OF SENSITIVITY AND/OR ALLERGY TO ADHESIVES BY CALLING (B)(6).

    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
    282295 LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR DSI LIFEWATCH SERVICES, INC. MCT 3L UNKNOWN/UNREPORTED 00850725007033

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other