BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSENSOR DIAGNOSTIC ECG ELECTRODES

    MDR report key: 4948997 · Received July 28, 2015

    Report

    Report Number
    4948997
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 28, 2015
    Manufacturer
    LEAD-LOK, INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THESE PATCHES LEFT A BROWN RESIDUE ON THE PATIENT'S CHEST. THE NURSE LOOKED DOWN AT THESE PATCHES AND THEY WERE RUSTED OVER. THERE WERE A COUPLE MORE IN THE PACKAGE THAT LOOKED THE SAME (RUSTY).PACKAGING WAS INTACT. THE ELECTRODES ARE STORED IN A TEMPERATURE AND HUMIDITY CONTROLLED ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490572 ACCUSENSOR DIAGNOSTIC ECG ELECTRODES ELECTRODE, ELECTROCARDIOGRAPH DRX LEAD-LOK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *