BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8018514

    MDR report key: 8018514 · Received October 30, 2018

    Report

    Report Number
    8018514
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 26, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NOTED A SKIN TEAR ON THE LEFT LATERAL BACK AND RIGHT UPPER SCAPULA AREA AFTER GENTLY REMOVING THE R2 PADS. VISIBLE SKIN MARKS ON THE PADS. LOT # Y013118-01, MODEL 335561REG, MONOPHASIC OR BIPHASIC COMPATIBLE DEFIBRILLATION CARDIOVERSION PACING ECG MONITORING ELECTRODES, MANUFACTURER REGARD. COMPARABLE TO PHYSIO-CONTROL QUICK-COMBO ELECTRODE. PRODUCT NOT AVAILABLE FOR RETURN.

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Other