BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PADPRO LLC

    MDR report key: 450375 · Received March 28, 2003

    Report

    Report Number
    450375
    Event Type
    Malfunction
    Date Received
    March 28, 2003
    Date of Event
    March 7, 2003
    Report Date
    March 27, 2003
    Manufacturer
    PADPRO LLC
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BURN MARKS FROM DEFIBRILLATOR PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PADPRO LLC DEFIBRILLATOR PADS MLN PADPRO LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other