BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1215631 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00052
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    September 26, 2006
    Report Date
    October 20, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. PER SALES REP, THE DOCTOR ACCIDENTALLY SHEARED THE CATHETER WHEN IMPLANTING IT.

    Description of Event or Problem · 1

    SEPTUM WAS LEAKING POST PLACEMENT OR POSSIBLE CATHETER DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK DQO ANGIODYNAMICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention