BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMOSITE

    MDR report key: 54318 · Received August 7, 1996

    Report

    Report Number
    54318
    Event Type
    Injury
    Date Received
    August 7, 1996
    Date of Event
    May 30, 1996
    Report Date
    June 6, 1996
    Manufacturer
    DEVICE LABS, INC.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RIGHT SIDED CATHETER REMOVED ON 5/30/96 DUE TO LEAKAGE AND BLOCKAGE CONFIRMED BY CHEST FLUOROSOCPY ON 5/14/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMOSITE Implant IMPLANTED CATHETER LJT DEVICE LABS, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention
    2