BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATO MEDICAL CORP.

    MDR report key: 189286 · Received September 24, 1998

    Report

    Report Number
    189286
    Event Type
    Injury
    Date Received
    September 24, 1998
    Date of Event
    September 12, 1998
    Report Date
    September 24, 1998
    Manufacturer
    HORIZON MEDICAL PRODUCTS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF 'PORTA-CATH', THE LOCK WAS FOUND NOT TO BE ATTACHED AND THE CATHETER MIGRATED INTO THE SUBCLAVIAN VEIN, NECESSITATING ANOTHER PROCEDURE. UNDER RADIOLOGY INTERVENTION, THE CATHETER WAS REMOVED. THE PT DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO MEDICAL CORP. Implant PORTA-CATH LJT HORIZON MEDICAL PRODUCTS * 14268

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention