BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9806722 · Received March 9, 2020

    Report

    Report Number
    3008642652-2020-01923
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 16, 2020
    Report Date
    March 5, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A FINE, ITCHY RASH ON LEFT UPPER BACK. SOME AREAS ARE NOW SCABBED OVER. PATIENT REPORTED A PHYSICIAN STATED THE RASH MAY BE A REACTION TO A MEDICATION THAT PT WAS ON PREVIOUSLY. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. PATIENT REPORTED THAT A PHYSICIAN INSTRUCTED HER TO TAKE ZYRTEC AND USE GENTIAN VIOLET SOLUTION ON THE RASH. FOLLOW UP INDICATED THAT THE SOLUTION IS HELPING WITH THE SKIN IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270962 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R