BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8701250 · Received June 14, 2019

    Report

    Report Number
    3008642652-2019-04563
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPATIBILITY TESTING TO ISO 10993 WAS SUCCESSFULLY COMPLETED ON SKIN-CONTACTING SURFACES OF THE LIFEVEST DEVICE AS WELL AS THE BLUE(TM) DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT THE PATIENT HAD DEVELOPED A RASH ON HER BACK UNDER THE TWO THERAPY ELECTRODE PADS. THE RASH WAS DESCRIBED AS IRRITATED, RED, SHINY, AND ITCHY. THE PATIENT'S DOCTOR PRESCRIBED A BENADRYL CREAM AND CORTIZONE CREAM. THE PATIENT'S DOCTOR ALSO ENDED USE OF THE LIFEVEST. THE PATIENT'S MEDICAL OUTCOME IS UNKNOWN AS THE PATIENT ENDED USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494074 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R