BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST SEMI-FLEX, 25CM

    MDR report key: 1053548 · Received May 28, 2008

    Report

    Report Number
    1056436-2008-00023
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERICARDIAL INFUSION OCCURRED AFTER PLACEMENT OF PROBE AND INITIATION OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST SEMI-FLEX, 25CM RF PROBE GEI ANGIODYNAMICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention