BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA

    MDR report key: 2318844 · Received October 28, 2011

    Report

    Report Number
    2951580-2011-00211
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 11, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE AND GENDER HAVE BEEN REQUESTED BUT WERE NOT RECEIVED. REFERENCE MANUFACTURER'S REPORT NO.: 2951580-2011-00212.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING AN EVAC 70 XTRA WAND AND COBLATOR II CONTROLLER, IT WAS REPORTED THAT THE PATIENT SUSTAINED A LIP BURN. THE DEGREE AND SEVERITY OF THE BURN WERE NOT AVAILABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. B220010-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention