BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATO MEDICAL CORP.

    MDR report key: 188605 · Received September 23, 1998

    Report

    Report Number
    188605
    Event Type
    Injury
    Date Received
    September 23, 1998
    Date of Event
    September 8, 1998
    Report Date
    September 10, 1998
    Manufacturer
    HORIZON MEDICAL PRODUCTS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORTA-CATH IMPLANTED 8/7/98 IS NON-FUNCTIONING. EXPLANTED - 9/8/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO MEDICAL CORP. PORTA-CATH LJT HORIZON MEDICAL PRODUCTS * 14565

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention