BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAD PRO LLC

    MDR report key: 461345 · Received May 21, 2003

    Report

    Report Number
    461345
    Event Type
    Other
    Date Received
    May 21, 2003
    Date of Event
    April 2, 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

    PT HAD EP STUDY IN 2003 IN WHICH THEY WERE DEFIBRILLATED ONCE AT 360 J. THE NEXT DAY THEY WERE BROUGHT BACK TO EP LAB TO HAVE ICD PLACED. IT WAS AT THIS TIME STAFF NOTED REDDENED AREAS ON THEIR CHEST JUST RIGHT OF THE STERNUM AND ON THEIR BACK ON THE LEFT JUST BELOW SCAPULA. BOTH REDDENED AREAS WERE CONSISTENT WITH SIZE, SHAPE AND AREA WERE DEFIB PADS WERE PLACED THE DAY BEFORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other