BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIO MEDICAL CARDIO CLEAR DEFIBRILLATOR PADS

    MDR report key: 10453870 · Received August 25, 2020

    Report

    Report Number
    MW5096272
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 24, 2020
    Manufacturer
    CARDIO MEDICAL PRODUCTS, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CARDIOVERSION USING CARDIO MEDICAL PRODUCT CARDIO CLEAR DEFIBRILLATOR PADS. THE PATIENT WAS SHOCKED WITH 150 JOULES, 200 JOULES AND THEN 200 JOULES. IMMEDIATELY AFTER THE PROCEDURE, THE PADS WERE REMOVED. THE PATIENT SUSTAINED A RED, RAISED OUTLINE ON HIS SKIN. THERE WAS A DEMARCATION THAT OUTLINED THE PERIMETER OF THE ANTERIOR PAD. PATIENT COMPLAINED OF A SKIN BURN AT THE ANTERIOR CHEST SITE. DR EXAMINED AND REQUESTED THAT SILVERDENE BE ORDERED TO THE SITE. FREQUENCY: APPLIED ONCE. ROUTE: CUTANEOUS; ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911120 CARDIO MEDICAL CARDIO CLEAR DEFIBRILLATOR PADS DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD CARDIO MEDICAL PRODUCTS, INC. Y060920-01

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other