BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY

    MDR report key: 9885388 · Received March 26, 2020

    Report

    Report Number
    3027765-2020-00003
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    February 28, 2020
    Report Date
    May 14, 2020
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    UDI-DI
    00850725007040
    PMA / PMN Number
    K151269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 DESCRIBED AS "SEVERE ALLERGY". THE PATIENT WAS ALLEGEDLY PRESCRIBED TOPICORT BY A HEALTHCARE PROVIDER. BASED ON INFORMATION AVAILABLE THE PATIENT ONLY WORE THE DEVICE FOR ONE DAY, AND THEN DID NOT WANT TO CONTINUE. NO NEW UPDATES ARE AVAILABLE, THE PATIENT ENDED THE ENROLLMENT. SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. THE MCT-1L USER GUIDE (SUP559 REV. D) INCLUDES WARNING STATEMENTS STATING THE FOLLOWING: THE MCT 1LP IS NOT INTENDED FOR USE ON PATIENTS WITH SKIN ORSOFT TISSUE DAMAGE IN THE AREA WHERE THE PATCH IS PLACED(SUCH AS BURNS, IRRITATION, INFECTIONS, WOUNDS, ETC.). IF YOU DEVELOP A SKIN IRRITATION, REMOVE THE MCT 1LP AND SEEK MEDICAL ATTENTION. REDDENING OR SLIGHT IRRITATION OF THE SKIN FROM THE MCT 1LP IS NORMAL. CONTACT LIFEWATCH SERVICES 1.800.517.6330 IF YOU EXPERIENCE ANY IRRITATION PROBLEMS. THE PATIENT CONTACTING MATERIALS OF THE PATCH SYSTEM HAVE BEEN TESTED FOR CYTOTOXICITY, SENSITIZATION AND SKIN IRRITATION PER THE FOLLOWING STANDARDS: CYTOTOXICITY ISO 10993-5. SENSITIZATION ISO 10993-10. IRRITATION ISO 10993-10. 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

    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 DESCRIBED AS "SEVERE ALLERGY". THE PATIENT WAS ALLEGEDLY PRESCRIBED TOPICORT BY A HEALTHCARE PROVIDER. BASED ON INFORMATION AVAILABLE THE PATIENT ONLY WORE THE DEVICE FOR ONE DAY, AND THEN DID NOT WANT TO CONTINUE. NO NEW UPDATES ARE AVAILABLE, THE PATIENT ENDED THE ENROLLMENT. SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. THE MCT-1L USER GUIDE (SUP559 REV. D) INCLUDES WARNING STATEMENTS STATING THE FOLLOWING: THE MCT 1LP IS NOT INTENDED FOR USE ON PATIENTS WITH SKIN ORSOFT TISSUE DAMAGE IN THE AREA WHERE THE PATCH IS PLACED(SUCH AS BURNS, IRRITATION, INFECTIONS, WOUNDS, ETC.). IF YOU DEVELOP A SKIN IRRITATION, REMOVE THE MCT 1LP AND SEEK MEDICAL ATTENTION. REDDENING OR SLIGHT IRRITATION OF THE SKIN FROM THE MCT 1LP IS NORMAL. CONTACT LIFEWATCH SERVICES 1.800.517.6330 IF YOU EXPERIENCE ANY IRRITATION PROBLEMS. THE PATIENT CONTACTING MATERIALS OF THE PATCH SYSTEM HAVE BEEN TESTED FOR CYTOTOXICITY, SENSITIZATION AND SKIN IRRITATION PER THE FOLLOWING STANDARDS: CYTOTOXICITY ISO 10993-5, SENSITIZATION ISO 10993-10, IRRITATION ISO 10993-10. 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
    350278 LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY DSI LIFEWATCH SERVICES, INC. MCT 1L UNKNOWN/UNREPORTED 00850725007040

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other