BEUDAMED
    FDA Adverse Event Summary report: N

    E-CARDIO

    MDR report key: 2980710 · Received February 25, 2013

    Report

    Report Number
    MW5029129
    Date Received
    February 25, 2013
    Date of Event
    November 3, 2011
    Report Date
    February 25, 2013
    Manufacturer
    E-CARDIO
    Product Code
    MWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED THE DEVICE IN (B)(6) 2011, ORDERED BY HER PHYSICIAN TO BE WORN FOR 10 DAYS. THE FIRST MONITOR STOPPED WORKING RIGHT AFTER SHE LEFT THE DOCTOR'S OFFICE. PT WAS GIVEN ANOTHER MONITOR WITH LATEX FREE LEADS BECAUSE OF HER SEVERE ALLERGIES. ON (B)(6) 2011, SHE CALLED THE MANUFACTURER BECAUSE SHE HAD STARTED EXPERIENCING BURNING FROM THE LEADS. SHE WAS SEEN AT THE EMERGENCY ROOM WITH A DIAGNOSIS OF CHEMICAL BURNS, SCARRING ON CHEST AND ABDOMEN. SHE WAS REFERRED TO A PLASTIC SURGEON WHO PRESCRIBED BLEACHING CREAMS FOR HER SCARS. PT IS IN PAIN, INSOMNIA AND IS SEEKING COMPENSATION FROM THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79484 E-CARDIO HOLTER MONITOR MWJ E-CARDIO ER920W

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R