BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-CHANNEL HOLTER MONITOR CARDIOKEY

    MDR report key: 8780756 · Received July 11, 2019

    Report

    Report Number
    2133409-2019-00008
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    MWJ
    PMA / PMN Number
    K130294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER INVESTIGATION OF EVENTS, THE PATIENT FIRST STARTED USING THE DEVICE ON (B)(6) 2019, AFTER RECEIVING IT FROM THE CLINIC. THE PATIENT/CAREGIVER INDICATED THAT THE ELECTRODES (VERMED A10091-5) WERE CHANGED EVERY TWO DAYS AFTER SHOWERING AND LETTING THE SKIN AIR DRY. HIBICLENS WIPES WERE USED TO CLEAN THE SKIN. SKIN IRRITATION AND REDDENING DEVELOPED, WITH GRADUAL WORSENING OVER THE COURSE OF SIX DAYS (NO SKIN BREAKAGE). ON (B)(6) 2019, THE PATIENT/CAREGIVER WENT TO THE CLINIC FOR OBSERVATION/COUNSELING AND ASKED FOR ANOTHER TYPE OF ELECTRODE TO WEAR. THE CLINIC PROVIDER SQUARE CLOTH ELECTRODES (VERMED VMH361 REV. B) THAT HAD BEEN PROVIDED BY DISTRIBUTOR (CARDIONET), DUE TO SKIN IRRITATION. THE SKIN IRRITATION WORSENED, WITH SKIN BREAKAGE, OOZING, REDNESS AND PAIN. THE CLOTH ELECTRODES WERE CHANGED EVERY DAY AFTER SHOWERING, AS THEY WOULD NOT STAY ON IN THE SHOWER. THE PATIENT'S CAREGIVER DID NOT TREAT THE BROKEN SKIN, EXCEPT KEEPING IT CLEAN AND DRY. IT WAS REPORTED THAT OINTMENTS APPEARED TO IRRITATE THE SKIN. THE SKIN APPEARS TO BE HEALING. THE AFFECTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE (B)(6) ACCOUNT EXECUTIVE RECEIVED A COMMUNICATION FROM AN ACCOUNT REGARDING PEDIATRIC PATIENT SKIN IRRITATION WHEN USING CARDIOKEY DEVICE. THE PATIENT WAS SWITCHED TO CLOTH ELECTRODES AS AN ALTERNATIVE. THE PATIENT'S CAREGIVER WANTED TO OBTAIN MORE INFORMATION ABOUT WHAT COMPONENTS OF THE ELECTRODE COULD CAUSE THE SKIN IRRITATION, AS THE PATIENT WILL NEED TO WEAR MONITORS IN THE FUTURE. AFTER EIGHT DAYS WEARING THE SYSTEM, THE PATIENT'S CAREGIVER REPORTED SKIN OOZING, REDNESS, ITCHINESS, AND PAIN. NOTE: MANUFACTURER BECOME AWARE DATE IS 06/14/2019, BASED ON RECEIPT OF ADDITIONAL INFORMATION FROM PATIENT/CAREGIVER BY BRAEMAR MANUFACTURING, LLC AND CLINICAL AFFAIRS REVIEW AND REPORTABILITY DETERMINATION, DUE TO PEDIATRIC PATIENT STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574804 1-CHANNEL HOLTER MONITOR CARDIOKEY 1-CHANNEL HOLTER MONITOR CARDIOKEY MWJ BRAEMAR MANUFACTURING, LLC 100-0030-01

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other