BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE CHEMOSITE IMPLANTABLE VENOUS ACCESS

    MDR report key: 84817 · Received April 15, 1997

    Report

    Report Number
    1219930-1997-00837
    Event Type
    Injury
    Date Received
    April 15, 1997
    Date of Event
    February 3, 1997
    Report Date
    March 17, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    09/15/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE BROKEN CATHETER WAS RETRIEVED THROUGH THE ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE CHEMOSITE IMPLANTABLE VENOUS ACCESS Implant IMPLANTABLE DRUG DELIVERY SYSTEM LJT UNITED STATES SURGICAL CORP. NA N5M107

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention