BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12268328 · Received August 3, 2021

    Report

    Report Number
    3008642652-2021-06723
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 29, 2021
    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 · 0

    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 · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT DEVELOPED A SKIN IRRITATION. THE IRRITATION WAS UNDER THE LEFT AND RIGHT ELECTRODE. THE IRRITATION WAS DESCRIBED AS RED, SLIMMY, WITH SKIN PEELING. THERE ARE NO ALLEGATIONS OF ANY BLEEDING, OOZING, OR WEEPING WOUNDS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT USED NEOSPORIN AND A BANDAGE AS RECOMMENDED BY THE RN. FOLLOW UP INDICATED THE IRRITATION IMPROVED AS THE PATIENT CHANGED THE GARMENTS MORE FREQUENTLY. SUPPLEMENTAL REPORT 9/29/2021: SUBMITTING REPORT TO CORRECT SECTION G4.

    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 SKIN IRRITATION. THE IRRITATION WAS UNDER THE LEFT AND RIGHT ELECTRODE. THE IRRITATION WAS DESCRIBED AS RED, SLIMMY, WITH SKIN PEELING. THERE ARE NO ALLEGATIONS OF ANY BLEEDING, OOZING, OR WEEPING WOUNDS. THERE WAS NO ALLEGED DEVICE MALFUNCTION CONTRIBUTING TO THE IRRITATION. THE PATIENT USED NEOSPORIN AND A BANDAGE AS RECOMMENDED BY THE RN. FOLLOW UP INDICATED THE IRRITATION IMPROVED AS THE PATIENT CHANGED THE GARMENTS MORE FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162859 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R