BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XL, 9 ARRAY, 3-5CM, 10CM

    MDR report key: 2439621 · Received January 10, 2012

    Report

    Report Number
    1056436-2011-00062
    Event Type
    Other
    Date Received
    January 10, 2012
    Date of Event
    October 14, 2011
    Report Date
    January 9, 2012
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED. HOWEVER THE CAUSE OF THE BROKEN TINE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE OF BREAST RFA BY XL. ONE TINE WAS BROKEN AND FELL OFF DURING FIRST DEPLOYMENT. IT WAS TAKEN OUT FROM THE PT FINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XL, 9 ARRAY, 3-5CM, 10CM RFA PROBE GEI ANGIODYNAMICS, INC. NA 543899

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other