BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAD PRO

    MDR report key: 322862 · Received March 26, 2001

    Report

    Report Number
    322862
    Event Type
    Other
    Date Received
    March 26, 2001
    Date of Event
    March 14, 2001
    Report Date
    March 20, 2001
    Manufacturer
    MEDICAL DEVICES INC
    Product Code
    MLN
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIOVERSION PROCESS PATIENT SUSTAINED 2 SMALL BURNS ON ANTERIOR CHEST. A LOUD POPPING SOUND WAS HEARD WHEN CARDIOVERSION WAS ADMINISTERED. THERE ARE TWO SMALL BURN MARKS ON THE CHEST DEFIBRILLATOR PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13371 PAD PRO DEFIBRILLATOR PAD MLN MEDICAL DEVICES INC 2001 Y011901-5

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other