BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGACLIP CLIP APPLIER-EXACT CODE UNKNOWN

    MDR report key: 514518 · Received February 25, 2004

    Report

    Report Number
    MW1031315
    Event Type
    Death
    Date Received
    February 25, 2004
    Date of Event
    February 28, 2002
    Report Date
    February 19, 2004
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    INCOMPLETE REPORT SUBMITTED BY MFR. FAILURE BY MFR AND MEDICAL FACILITIES TO TIMELY REPORT TO THE FDA PER SEC 803.10-A-10-I, 803.53 AND FAILURE OF MEDICAL FACILITY TO COMPLY WITH SEC 803.32, 803.33, 803.40, 803.42. BELATED AND INCOMPLETE REPORT NUMBER 1527736-2003-02630.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP CLIP APPLIER-EXACT CODE UNKNOWN CLIP APPLIERS GDO ETHICON ENDO-SURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death