BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOTRONICS R2

    MDR report key: 330498 · Received April 30, 2001

    Report

    Report Number
    MW1021778
    Event Type
    Other
    Date Received
    April 30, 2001
    Date of Event
    April 24, 2001
    Report Date
    April 26, 2001
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    MLN
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH ACCELERATED HYPERTENSION AND ATRIAL FIBRILLATION CARDIOVERTED WITH 200J X 1. RECEIVED BURNS ON ANTERIOR CHEST WHERE PADS WERE LOCATED. BURN AROUND OUTER RIM OF PAD BUT NOT ON INTERIOR. MD ORDERED SILVADENE CREAM BID AND PRN TO BURN AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19805 CARDIOTRONICS R2 ELECTRODES/DEFIB PADS MLN BALLARD MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other