BEUDAMED
    FDA Adverse Event Summary report: N

    MEDI-TRACE, CADENCE

    MDR report key: 2110237 · Received May 25, 2011

    Report

    Report Number
    2110237
    Date Received
    May 25, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    HEARTSTREAM EQUIVALENT PAD #22660R. WHEN PAD IS REMOVED FROM PATIENT'S SKIN, THE PAD ADHESIVE ALSO REMOVES THE PATIENT'S SKIN.MANUFACTURER RESPONSE FOR ELECTRODE, DEFIBRILLATOR, MEDI-TRACE, CADENCE (PER SITE REPORTER): ONLY SALES REP MADE AWARE OF ISSUE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TRACE, CADENCE ELECTRODE, DEFIBRILLATOR MKJ COVIDIEN, FORMERLY KENDALL A DIVISION OF TYCO HEALTHCARE 22660R *

    Patients

    Seq Age Sex Outcome Treatment
    1 *