BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST ZLI ENHANCED SEM-FLEX, 25CM, FLEXIBL

    MDR report key: 2742501 · Received September 10, 2012

    Report

    Report Number
    1056436-2012-00084
    Event Type
    Injury
    Date Received
    September 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING RFA OF LUNG LESION, PT HAD EXCESSIVE BLEEDING FROM MOUTH, APPROXIMATELY 200 CC'S. DECISION MADE TO ABORT CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST ZLI ENHANCED SEM-FLEX, 25CM, FLEXIBL RFA PROBE GEI ANGIODYNAMICS NA 578908

    Patients

    Seq Age Sex Outcome Treatment
    1