BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR

    MDR report key: 11265455 · Received February 1, 2021

    Report

    Report Number
    MW5099128
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    December 5, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BARDY DIAGNOSTICS INC.
    Product Code
    DSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A PROBLEM WITH BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR. IT WAS PUT ON AT MY DOCTOR'S OFFICE ON (B)(6) 2020 FOR A TWO WEEK TEST. I WAS TOLD IT WAS OK TO SHOWER AS LONG AS I DIDN'T LET WATER DIRECTLY STREAM ONTO THE DEVICE, AND THE SHOWER WAS BRIEF. 3 DAYS LATER ON A SATURDAY, AFTER 3 BRIEF SHOWERS, ABOUT HALF OF THE DEVICE FELL OFF. ALTHOUGH I HAD NO IDEA IF THE MONITOR STILL WORKED, I USED WATERPROOF TAPE AND TAPED IT BACK ONTO MY CHEST. WHEN I SPOKE TO THE DOCTOR ON THE FOLLOWING MONDAY, THEY, TOO, HAD NO IDEA IF IT WAS STILL OBTAINING VALID DATA. FOR THE REST OF THE TEST PERIOD, I JUST APPLIED FRESH WATERPROOF TAPE EVERY DAY TO HOLD IT IN PLACE. I HAD TO ABORT THE TEST AFTER 8 OR 9 DAYS BECAUSE I JUST COULDN'T KEEP IT STUCK TO MY CHEST EVEN WITH THE ADDITIONAL TAPE. IN SUMMARY, I BELIEVE THE ADHESIVE ON THE DEVICE WAS INADEQUATE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153430 BARDY DIAGNOSTICS CARNATION AMBULATORY MONITOR RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS INC. B1000R1400 083120

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR