BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAD PRO LLC

    MDR report key: 461338 · Received May 21, 2003

    Report

    Report Number
    461338
    Event Type
    Other
    Date Received
    May 21, 2003
    Date of Event
    May 12, 2003
    Report Date
    May 14, 2003
    Manufacturer
    PAD PRO
    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

    WHILE PREPPING PT FOR ICD IMPLANT, NOTED REDDENED AREAS ON LEFT CHEST AND RIGHT UPPER BACK IN THE SHAPE OF THE DEFIBRILLATOR PADS THAT WERE USED ON PT THE DAY BEFORE. PT WAS DEFIBRILLATED ONCE WITH 360 J. SKIN COLOR IS MEDIUM. PT COMPLAINED OF ITCHING/PAIN. TREATED WITH SILVADENE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAD PRO LLC DEFIBRILLATOR PADS MLN PAD PRO * Y091702-7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other