BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO XT PATCH

    MDR report key: 13486999 · Received February 8, 2022

    Report

    Report Number
    3007208829-2022-00110
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 21, 2022
    Report Date
    August 8, 2022
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSH
    PMA / PMN Number
    K121319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. CLINICAL REF. MANUAL (NLB0020) WARNINGS STATE THE FOLLOWING: DO NOT USE THE ZIO XT PATCH ON PATIENTS WITH KNOWN ALLERGIC REACTION TO ADHESIVES OR HYDROGELS OR WITH FAMILY HISTORY OF ADHESIVE SKIN ALLERGIES. PATIENT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS, ITCHING OR ALLERGIC SYMPTOMS DEVELOP, REMOVE THE ZIO XT PATCH FROM THE PATIENT¿S CHEST.

    Additional Manufacturer Narrative · 0

    THE POTENTIAL FOR SKIN IRRITATION AND ALLERGIC REACTION IS A KNOWN INHERENT RISK OF THE DEVICE. THE FOLLOWING IS AN EXCERPT FROM DEVICE WARNINGS: DO NOT USE THE ZIO XT PATCH ON PATIENTS WITH KNOWN ALLERGIC REACTION TO ADHESIVES OR HYDROGELS OR WITH FAMILY HISTORY OF ADHESIVE SKIN ALLERGIES. PATIENT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS, ITCHING OR ALLERGIC SYMPTOMS DEVELOP, REMOVE THE ZIO XT PATCH FROM THE PATIENT¿S CHEST. IRHYTHM TECHNOLOGIES, INC. CONDUCTED A 2-YEAR REVIEW OF SUBMITTED MDRS. THE BULK OF THESE RECORDS WERE REPORTED BECAUSE THE EVENT INVOLVED A PATIENT WHO WAS TREATED BY A MEDICAL PROFESSIONAL FOR MINOR SKIN INJURIES/IRRITATIONS. MOST OF THESE TREATMENTS WERE NOT PRESCRIBED IN ORDER TO PREVENT PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION, AND THEREFORE DO NOT MEET THE REQUIREMENTS FOR MANDATORY REPORTING. ALL FORMS OF CONTACT DERMATITIS ARE CLASSIFIED AS LOWER ACUITY, AS PATIENTS TYPICALLY PRESENT WITH SYMPTOMS THAT HAVE A LOW PROBABILITY OF PROGRESSION TO MORE SERIOUS DISEASE OR DEVELOPMENT OF COMPLICATIONS (REF. 2019 MODEL OF THE CLINICAL PRACTICE OF EMERGENCY MEDICINE). ALSO, USING THE PALMER METHOD TO ESTIMATE TOTAL BODY SURFACE AREA (TBSA), THE DEVICE FOOTPRINT COVERS LESS THAN 1% TBSA. AS SUCH, SKIN INJURIES RESULTING FROM THE DEVICE AFFECT A RELATIVELY SMALL AREA AND ARE UNLIKELY TO IMPACT THE FUNCTION OF THE PATIENT¿S SKIN AS A WHOLE WHEN CONSIDERED AS AN ORGAN (E.G. ESSENTIAL FUNCTIONS OF THERMOREGULATION, PREVENTION OF INFECTION/DEHYDRATION, SENSING OF TOUCH/TEMPERATURE, STORAGE OF FAT/WATER/BLOOD/METABOLIC PRODUCTS, ABSORPTION/EXCRETION, VITAMIN D PRODUCTION, ETC). BASED ON THIS INFORMATION, IRHYTHM¿S QUALITY COMPLIANCE DEPARTMENT WILL CEASE REPORTING THE AFOREMENTIONED ISSUES, UNLESS THE SKIN IRRITATION OR ALLERGIC REACTION LED TO SERIOUS INJURY, IN ORDER TO MORE CLOSELY ALIGN WITH THE DEFINITION OF MANDATORY REPORTING REQUIREMENTS STATED IN 21 CFR PART 803.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THEIR HEALTHCARE PROVIDER WITH A PROBABLE CONTACT DERMATITIS WHERE TREATMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706392 ZIO XT PATCH RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention