BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2101172 · Received May 18, 2011

    Report

    Report Number
    2951580-2011-00066
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THE LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    DURING AN ACROMIOPLASTY PROCEDURE WITH AN ULTRAVAC 90 WITH INTEGRATED CABLE ARTHROWAND, THE PT SUSTAINED A FIRST DEGREE BURN, ON THE LEFT SHOULDER AT THE LATERAL PORTAL, APPROX 2 CM X 2 CM IN SIZE. REPORTEDLY, THE BURN WAS TREATED WITH PASTA BETADINE. THE PHYSICIAN'S OPINION OF THE CAUSE OF THE BURN WAS REPORTED AS DUE TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other