BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBL

    MDR report key: 2717159 · Received August 24, 2012

    Report

    Report Number
    1056436-2012-00082
    Event Type
    Injury
    Date Received
    August 24, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 24, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), A FEMALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN OSTEOID OSTOMA ABLATION USING RADIOFREQUENCY. THE CASE WAS PERFORMED WITH A NORMAL SET UP. THE THERMO PADS WERE PLACED BY THE TREATING PHYSICIAN SET THE PADS. THE CASE WAS SUCCESSFULLY COMPLETED WITH NOT COMPLICATIONS NOTED. THERE WAS NO INDICATION OF A GENERATOR, PROBE FOR BURN PAD MALFUNCTION. NO PATIENT INJURY NOTED AT END OF THE PROCEDURE. ALL DISPOSABLE DEVICES WERE DISPOSED OF AT THE COMPLETION OF THE CASE. A FOLLOW UP WITH THE PATIENT APPROX 3-4 DAYS LATER NOTED SKIN BURNS ON THE THIGH. THEY REPORTED AS BEING SMALL ABOUT QUARTER SIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBL RF PROBE GEI ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other