BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING

    MDR report key: 3874995 · Received June 2, 2014

    Report

    Report Number
    3006524618-2014-00169
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    June 22, 2013
    Report Date
    May 5, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING AN AMBIENT SUPER TURBOVAC 90 IFS WAND, THE PT ALLEGEDLY SUSTAINED A DERMAL BURN ACROSS THE CHEST AND UPPER SHOULDER. THE BURN WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED WHILE THE PT WAS GETTING DRESSED. THE BURN WAS EXAMINED AND THEN DRESSED BY A NURSE BEFORE THE PT WAS DISCHARGED. NO FURTHER TREATMENT WAS PROVIDED REGARDING THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321865 AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other