BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBLATOR II

    MDR report key: 3912791 · Received June 13, 2014

    Report

    Report Number
    3006524618-2014-00195
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    September 1, 2013
    Report Date
    June 11, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT SUFFERED A POST OPERATIVE RE-BLEED 4 DAYS AFTER A TONSILLECTOMY PROCEDURE THAT ALLEGEDLY INVOLVED AN UNKNOWN ARTHROWAND. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PROCEDURE, THE PATIENT, THE TREATMENT OR THE OUTCOME. ARTHROCARE WILL CONTINUE TO MONITOR FOR FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350120 COBLATOR II OPERATOR CONSOLE DIATHERMY UNIT GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization