BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECG ELECTRODES

    MDR report key: 276586 · Received May 5, 2000

    Report

    Report Number
    MW1018822
    Event Type
    Injury
    Date Received
    May 5, 2000
    Date of Event
    May 3, 2000
    Report Date
    May 5, 2000
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY IS PLANNING TO USE ELECTRODES IN A RESEARCH STUDY INVOLVING THE ELDERLY POPULATION. WHEN RPTR TESTED THE DEVICE, REDNESS AND WELTS WERE EXPERIENCED ON THE CHEST AREA. THE REACTION WAS WITHIN 40 MINS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG ELECTRODES ECG ELECTRODES DRX CAMBRIDGE HEART, INC. UNK 514509

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR