BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTEL HEART MONITOR DEVICE

    MDR report key: 7681217 · Received July 11, 2018

    Report

    Report Number
    MW5078331
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    March 1, 2018
    Report Date
    July 9, 2018
    Manufacturer
    CARDIONET / LIFEWATCH / BIOTELEMETRY, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS RECEIVED A HEART MONITOR DEVICE FROM BIOTEL, THE LEADS THEY SENT WERE NOT COMPATIBLE FOR MY SKIN. I NOTIFIED THE COMPANY AND WAS OFFERED NO RESOLUTION BUT MAILED A BILL WHEN I RETURNED THE DEFECTIVE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522420 BIOTEL HEART MONITOR DEVICE DETECTOR AND ALARM, ARRHYTHMIA DSI CARDIONET / LIFEWATCH / BIOTELEMETRY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other