BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATOR 2CM BLUE CALIBR

    MDR report key: 2433564 · Received July 20, 2011

    Report

    Report Number
    9616086-2011-00088
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 20, 2011
    Manufacturer
    DJO GLOBAL
    Product Code
    IPF
    PMA / PMN Number
    K062354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BURNED DURING COMBO TREATMENT; NEW U/S HEAD WAS USED; BIOMED IS UNSURE IF IT WAS THE ELECTRODES OR THE U/S HEAD. APPLICATOR WAS USED WITH THE VECTRA GENISYS 2CH COMBO DEVICE PART NUMBER 2761 SERIAL NUMBER (B)(4). NO OTHER PT INFO PROVIDED OR CONFIRMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLICATOR 2CM BLUE CALIBR ELECTROTHERAPY IPF DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other