BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER 2220

    MDR report key: 108110 · Received July 25, 1997

    Report

    Report Number
    1222632-1997-00076
    Event Type
    Injury
    Date Received
    July 25, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 25, 1997
    Manufacturer
    NITINOL MEDICAL TECHNOLOGIES, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FILTER FEET GOT STUCK AT INTRODUCER HUB JUNCTION. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. 1ST OF 2 REPORTS INVOLVING SAME PT (REFER TO MDR #1222632-1997-00077).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER 2220 Implant VENA CAVA FILTER DTK NITINOL MEDICAL TECHNOLOGIES, INC. 2220 515017B

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention