BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4448145 · Received January 21, 2015

    Report

    Report Number
    3008642652-2015-00270
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    November 2, 2014
    Report Date
    January 19, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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 DEFIBRILLATION GEL.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A US DISTRIBUTOR NOTIFIED ZOLL THAT A (B)(4) YEAR OLD MALE PT HAD A RASH UNDER THE FRONT THERAPY ELECTRODE PAD THAT HAD BEGUN TO BLEED. THE PT WAS USING A STEROID CREAM ON THE RASH. A FOLLOW-UP WITH THE PT ON (B)(6) 2014 INDICATED THAT THE PT WAS PRESCRIBED A CORTISONE AND A STEROID CREAM BUT THE IRRITATION HAD NOT YET HEALED. THERE IS NO FURTHER INFORMATION REGARDING THE PT'S SKIN CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50036 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other