BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCISE EZ VIEW

    MDR report key: 2921717 · Received January 15, 2013

    Report

    Report Number
    3006524618-2013-00039
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    May 9, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K022229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SEVERAL MONTHS AFTER A TONSILLECTOMY PROCEDURE USING THE PROCISE EZ VIEW WAND, THE PT ALLEGED THAT THE PROCEDURE CAUSED DISCOLORATION ON THE PT'S CHEEK. THE PROCEDURE WAS COMPLETED IN (B)(6) 2012 WITHOUT ANY REPORTED COMPLICATIONS UNTIL (B)(6) 2012. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23199 PROCISE EZ VIEW ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT KOG ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other