BEUDAMED
    FDA Adverse Event Summary report: N

    VECTRA GENISYS 2CH COMBO PKG

    MDR report key: 2112491 · Received March 29, 2011

    Report

    Report Number
    9616086-2011-00032
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    IMG
    PMA / PMN Number
    K031077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PTS HAVE BEEN BURNED BY UP TO 6 VECTRA GENISYS UNITS. INVESTIGATION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO PKG ELECTROTHERAPY IMG DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other