BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6142087 · Received December 2, 2016

    Report

    Report Number
    3008642652-2016-08851
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 A SKIN IRRITATION UNDER THE LIFEVEST. THE SKIN IRRITATION WAS DESCRIBED AS NEURODERMATITIS. THE PATIENT WAS PRESCRIBED DECODERM CREAM. THERE IS NO ALLEGED DEVICE MALFUNCTION. FOLLOW UP WITH THE PATIENT WAS COMPLETED AND THE SKIN IRRITATION WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792721 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention