BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDY DIAGNOSTIC CAM

    MDR report key: 12861511 · Received November 22, 2021

    Report

    Report Number
    MW5105519
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 18, 2021
    Manufacturer
    BARDY DIAGNOSTICS INC.
    Product Code
    DSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DUE TO A CARDIAC ISSUE AND EVENT THAT OCCURRED, MY CARDIOLOGIST ORDERED ME TO WEAR A HEART MONITOR FOR 14 DAYS TO GET A GOOD READING OF MY HEART AND TO SEE IF ANOTHER INCIDENT COULD BE RECORDED SO AS TO DETERMINE AN APPROPRIATE TREATMENT OR PROCEDURE TO CORRECT THE PROBLEM. THE BARDY DIAGNOSTIC CAM MONITOR WAS PLACED ON ME. BY THE 2ND DAY, THE EDGES OF THE ADHESIVE STRIPPING STARTED TO WARP AND ROLL, AND ON THE 3RD DAY THE CONDUCTION GEL SEPARATED FROM THE BOTTOM OF THE MONITOR AND FELL OFF. ANOTHER MONITOR WAS PLACED ON ME AND I WAS TOLD TO TAPE IT ON IF IT STARTED COMING OFF. I SHOULDN'T HAVE HAD TO TAPE IT, BUT DID SO WITH MEDICAL TAPE ON THE 2ND DAY. ON THE 3RD DAY, THE CONDUCTION GEL AGAIN SEPARATED AND DETACHED FROM THE MONITOR AND FELL OUT THE BOTTOM OF IT. THE MONITORS ARE OVER 300.00 NOT INCLUDING THE COST TO BE READ. I HAVE BEEN CHARGED FOR BOTH MONITORS AND THERE IS ABSOLUTELY NO WAY THAT THIS MONITOR WILL STAY ON ANYONE'S BODY FOR 14 DAYS. BECAUSE OF THE POOR QUALITY AND FAILURE OF THE MONITORS, I AM UNABLE TO COMPLETE MY DR'S ORDER IN COMPLIANCE OF A POTENTIALLY LIFE-THREATENING ISSUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755796 BARDY DIAGNOSTIC CAM RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS INC. B1400 031280
    1755797 BARDY DIAGNOSTIC CAM RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS INC. B1400

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female CORTICOSTEROID INJECTION| GABAPENTIN | IBUPROFEN| METFORMIN | METOPROLOL | OZEMPIC| TRAMADOL