BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASTICK PLUS

    MDR report key: 2103829 · Received May 24, 2011

    Report

    Report Number
    9616086-2011-00064
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    IPF
    PMA / PMN Number
    K953615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED BURNS WITH THE DURA-STICK PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASTICK PLUS ELECTROTHERAPY IPF DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other