BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATO MEDICAL CORP

    MDR report key: 187165 · Received September 10, 1998

    Report

    Report Number
    MW1014564
    Event Type
    Injury
    Date Received
    September 10, 1998
    Date of Event
    September 8, 1998
    Report Date
    September 10, 1998
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORTA-CATH WAS IMPLANTED ON 8-7-98, AND IS NOW NON-FUNCTIONING. EXPLANTED ON 9-8-98.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention