BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 673345 · Received October 28, 2005

    Report

    Report Number
    6000118-2005-00107
    Event Type
    Malfunction
    Date Received
    October 28, 2005
    Date of Event
    September 29, 2005
    Report Date
    September 29, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME AS CASE MANUFACTURER REPORT# 6000018-2005-00108. PRIOR TO A TREATMENT PROCEDURE TO PLACE A GREENFIELD VENA CAVA FILTER, THE FILTER DEPLOYED. THE FILTER WAS NOT USED IN THE PT, SO NO PT INJURIES OR COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12FR SS VENA CAVA FILTER VENA CAVA FILTERS DTK BOSTON SCIENTIFIC NA 7366489

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN