BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INT LEGEND COMBO 4C

    MDR report key: 2103831 · Received May 24, 2011

    Report

    Report Number
    9616086-2011-00062
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    IMI
    PMA / PMN Number
    K982829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INT LEGEND COMBO 4C ELECTROTHERAPY IMI DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other