BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUAL PACER/DEFIB PADS

    MDR report key: 294755 · Received September 11, 2000

    Report

    Report Number
    294755
    Event Type
    Other
    Date Received
    September 11, 2000
    Date of Event
    August 11, 2000
    Report Date
    September 6, 2000
    Manufacturer
    AGILENT TECHNOLOGIES
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR ELECTIVE CARDIOVERSION. PADS PLACED ON APICAL/APEX REGION OF CHEST. MD MOVED TO LEFT CHEST RIGHT BACK. PT DEFIBRILLATED WITH 200-300-360-360J. BURNED SKIN SMELLED IN ROOM AFTER CARDIOVERSION. BLISTERS NOTED ON SKIN UNDER PADS WHEN PADS REMOVED. SILVADENE CREAM APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL PACER/DEFIB PADS DUAL PACER/DEFIB PADS MLN AGILENT TECHNOLOGIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other