BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GEN 2C COMBO WITHOUT EMG

    MDR report key: 2051035 · Received April 4, 2011

    Report

    Report Number
    9616086-2011-00059
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 31, 2011
    Manufacturer
    DJ ORTHOPEDICS DE MEXICO
    Product Code
    IMG
    PMA / PMN Number
    K040285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED "CUSTOMER RECEIVED A DIME SIZE BURN FROM UNIT". THE UNIT PASSES INSPECTION. THE USER MANUAL INCLUDES THE FOLLOWING WARNINGS: KEEP ELECTRODES SEPARATED DURING TREATMENT. ELECTRODES IN CONTACT WITH EACH OTHER COULD RESULT IN IMPROPER STIMULATION OR SKIN BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GEN 2C COMBO WITHOUT EMG COMBO ELECTROTHERAPY/ULTRASOUND IMG DJ ORTHOPEDICS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other